Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT00038727
Status:
UNKNOWN
Last Update Posted:
2021-12-28
First Post:
2002-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Diabetes Prevention Program Outcomes Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ella@bsc.gwu.edu', 'phone': '3018819260', 'title': 'Marinella Temprosa, PI of Coordinating Center', 'organization': 'George Washington University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Until data lock of Jan 2014, average of 15 years of follow-up', 'eventGroups': [{'id': 'EG000', 'title': '1 Original Lifestyle', 'description': 'Boost / Lifestyle, previously Intensive Lifestyle during the DPP\n\nGroup Lifestyle: Quarterly group lifestyle sessions\n\nBoost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.', 'otherNumAtRisk': 916, 'deathsNumAtRisk': 916, 'otherNumAffected': 234, 'seriousNumAtRisk': 916, 'deathsNumAffected': 88, 'seriousNumAffected': 472}, {'id': 'EG001', 'title': '2 Original Metformin', 'description': 'Metformin / Lifestyle, previously the metformin treatment group during DPP\n\nGroup Lifestyle: Quarterly group lifestyle sessions\n\nMetformin: Administered as 850mg twice per day', 'otherNumAtRisk': 927, 'deathsNumAtRisk': 927, 'otherNumAffected': 274, 'seriousNumAtRisk': 927, 'deathsNumAffected': 85, 'seriousNumAffected': 482}, {'id': 'EG002', 'title': '3 Original Placebo', 'description': 'Group Lifestyle, previously placebo treated participants during DPP\n\nGroup Lifestyle: Quarterly group lifestyle sessions', 'otherNumAtRisk': 936, 'deathsNumAtRisk': 936, 'otherNumAffected': 257, 'seriousNumAtRisk': 936, 'deathsNumAffected': 83, 'seriousNumAffected': 492}], 'otherEvents': [{'term': 'Sprains and fractures requiring medical attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 234}, {'groupId': 'EG001', 'numAtRisk': 927, 'numAffected': 274}, {'groupId': 'EG002', 'numAtRisk': 936, 'numAffected': 257}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Costart dictionary'}], 'seriousEvents': [{'term': 'Any SAE Report', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numEvents': 1099, 'numAffected': 472}, {'groupId': 'EG001', 'numAtRisk': 927, 'numEvents': 1122, 'numAffected': 482}, {'groupId': 'EG002', 'numAtRisk': 936, 'numEvents': 1103, 'numAffected': 492}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Costart dictionary'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Development of Diabetes.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '916', 'groupId': 'OG000'}, {'value': '927', 'groupId': 'OG001'}, {'value': '936', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 Original Lifestyle', 'description': 'Boost / Lifestyle, previously Intensive Lifestyle during the DPP\n\nGroup Lifestyle: Quarterly group lifestyle sessions\n\nBoost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.'}, {'id': 'OG001', 'title': '2 Original Metformin', 'description': 'Metformin / Lifestyle, previously the metformin treatment group during DPP\n\nGroup Lifestyle: Quarterly group lifestyle sessions\n\nMetformin: Administered as 850mg twice per day'}, {'id': 'OG002', 'title': '3 Original Placebo', 'description': 'Group Lifestyle, previously placebo treated participants during DPP\n\nGroup Lifestyle: Quarterly group lifestyle sessions'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '5.8'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '7.1'}, {'value': '7.8', 'groupId': 'OG002', 'lowerLimit': '7.2', 'upperLimit': '8.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).', 'description': 'Primary outcome for years 2002-2008 defined according to American Diabetes Association criteria (fasting plasma glucose level \\>= 126 mg/dL \\[7.0 mmol/L\\] or 2-hour plasma glucose \\>= 200 mg/dL \\[11.1 mmol/L\\], after a 75 gram oral glucose tolerance test (OGTT), and confirmed with a repeat test).', 'unitOfMeasure': 'diabetes incidence (cases per 100 person', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Prevalence of Aggregate Microvascular Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '751', 'groupId': 'OG000'}, {'value': '772', 'groupId': 'OG001'}, {'value': '780', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 Original Lifestyle', 'description': 'Boost / Lifestyle, previously Intensive Lifestyle during the DPP\n\nGroup Lifestyle: Quarterly group lifestyle sessions\n\nBoost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.'}, {'id': 'OG001', 'title': '2 Original Metformin', 'description': 'Metformin / Lifestyle, previously the metformin treatment group during DPP\n\nGroup Lifestyle: Quarterly group lifestyle sessions\n\nMetformin: Administered as 850mg twice per day'}, {'id': 'OG002', 'title': '3 Original Placebo', 'description': 'Group Lifestyle, previously placebo treated participants during DPP\n\nGroup Lifestyle: Quarterly group lifestyle sessions'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '12.7'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '11.7', 'upperLimit': '14.5'}, {'value': '12.4', 'groupId': 'OG002', 'lowerLimit': '11.1', 'upperLimit': '13.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Outcomes were assessed from 2012-2013 (approximately 2 years).', 'description': 'Aggregate microvascular disease is defined as the average prevalence of 3 components: (1) retinopathy measured by photography (ETDRS of 20 or greater); (2) neuropathy detected by Semmes Weinstein 10 gram monofilament, and (3) nephropathy based on estimated glomerular filtration rate (eGFR by chronic kidney disease (CKD-Epi) equation ) (\\<45 ml/min, confirmed) and albumin-to-creatinine ratio in spot urine (\\> 30mg/gm, confirmed).', 'unitOfMeasure': 'average percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number with microvascular outcome data and included in the primary outcome analysis'}, {'type': 'PRIMARY', 'title': 'Total Cancer Except Non-melanoma Skin Cancer', 'timeFrame': 'Outcomes were assessed from 1996-2020 (approximately 24 years).', 'description': 'All primary incident cancers except non-melanoma skin cancer', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2022-01'}, {'type': 'PRIMARY', 'title': 'Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD)', 'timeFrame': 'Outcomes were assessed from 1996-2025 (approximately 29 years).', 'description': 'Defined as MI, stroke and CVD death. These outcomes were collected since randomization and adjudicated by an outcomes committee who are blinded to treatment assignment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-06'}, {'type': 'SECONDARY', 'title': 'Subclinical Atherosclerosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '679', 'groupId': 'OG001'}, {'value': '681', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 Original Lifestyle', 'description': 'randomized to unmasked Intensive Lifestyle during the DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle plus DPPOS Boost Lifestyle sessions in DPPOS Phase 1 and 2\n\nDPPOS Group Lifestyle: Quarterly group lifestyle sessions\n\nDPPOS Boost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.\n\nIntensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions'}, {'id': 'OG001', 'title': '2 Original Metformin', 'description': 'randomized to the masked metformin treatment group during DPP and continued open label in DPPOS. Participants were also offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2.\n\nDPPOS Group Lifestyle: Quarterly group lifestyle sessions\n\nMetformin: Administered as 850mg twice per day, masked in DPP and open label in DPPOS\n\nIntensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions'}, {'id': 'OG002', 'title': '3 Original Placebo', 'description': 'randomized to masked placebo during DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2\n\nDPPOS Group Lifestyle: Quarterly group lifestyle sessions\n\nIntensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions'}], 'classes': [{'title': 'Men', 'denoms': [{'units': 'Participants', 'counts': [{'value': '468', 'groupId': 'OG000'}, {'value': '464', 'groupId': 'OG001'}, {'value': '486', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '70.1', 'groupId': 'OG000', 'lowerLimit': '45.4', 'upperLimit': '108.2'}, {'value': '40.2', 'groupId': 'OG001', 'lowerLimit': '26.1', 'upperLimit': '61.9'}, {'value': '63.7', 'groupId': 'OG002', 'lowerLimit': '41.3', 'upperLimit': '98.3'}]}]}, {'title': 'Women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '8.8'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '9.0'}, {'value': '5.3', 'groupId': 'OG002', 'lowerLimit': '3.6', 'upperLimit': '7.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Outcomes were assessed from 2012-2013 (approximately 2 years).', 'description': 'Measured using coronary artery calcification (CAC).', 'unitOfMeasure': 'CAC geometric mean in AU', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'DPPOS Participants who met eligibility criteria and consented to have CAC measurements - by sex'}, {'type': 'SECONDARY', 'title': 'Cognitive Function', 'timeFrame': 'Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.', 'description': 'Cognitive function defined as a composite measure constructed from tests of memory (English Spanish Verbal Learning Test) and executive function (word fluency and Digit Symbol Substitution Test ).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2022-08'}, {'type': 'SECONDARY', 'title': 'Short Physical Performance Battery', 'timeFrame': 'Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.', 'description': 'Physical function is measured using the short physical performance battery (SPPB), which is comprised of measures of 1) time to walk 3-4 meters, 2) balance, i.e., side-by-side stand, semi-tandem stand, and tandem stand, and 3) repeated chair stands.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2022-08'}, {'type': 'SECONDARY', 'title': 'Frailty', 'timeFrame': 'Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.', 'description': 'Description: The Cardiovascular Health Study Frailty score is based on 5 frailty characteristics: slow walking speed, low energy expenditure, exhaustion, weak grip strength, and unintentional weight loss.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2022-08'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1079', 'groupId': 'OG000'}, {'value': '1073', 'groupId': 'OG001'}, {'value': '1082', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 Original Lifestyle', 'description': 'Boost / Lifestyle, previously Intensive Lifestyle during the DPP\n\nGroup Lifestyle: Quarterly group lifestyle sessions\n\nBoost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.'}, {'id': 'OG001', 'title': '2 Original Metformin', 'description': 'Metformin / Lifestyle, previously the metformin treatment group during DPP\n\nGroup Lifestyle: Quarterly group lifestyle sessions\n\nMetformin: Administered as 850mg twice per day'}, {'id': 'OG002', 'title': '3 Original Placebo', 'description': 'Group Lifestyle, previously placebo treated participants during DPP\n\nGroup Lifestyle: Quarterly group lifestyle sessions'}], 'classes': [{'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.28', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.95', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.25', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Outcomes were assessed throughout follow-up from 1996 to 2022. National Death Index search conducted in 2019 using early release data as of Dec 2018.', 'description': 'All cause-mortality through clinic reports and National Death Index search', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized to DPP were included'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 Original Lifestyle', 'description': 'Boost / Lifestyle, previously Intensive Lifestyle during the DPP\n\nGroup Lifestyle: Quarterly group lifestyle sessions\n\nBoost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.'}, {'id': 'FG001', 'title': '2 Original Metformin', 'description': 'Metformin / Lifestyle, previously the metformin treatment group during DPP\n\nGroup Lifestyle: Quarterly group lifestyle sessions\n\nMetformin: Administered as 850mg twice per day'}, {'id': 'FG002', 'title': '3 Original Placebo', 'description': 'Group Lifestyle, previously placebo treated participants during DPP\n\nGroup Lifestyle: Quarterly group lifestyle sessions'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Includes all enrollees from DPPOS 1-3', 'groupId': 'FG000', 'numSubjects': '916'}, {'comment': 'Includes all enrollees from DPPOS 1-3', 'groupId': 'FG001', 'numSubjects': '927'}, {'comment': 'Includes all enrollees from DPPOS 1-3', 'groupId': 'FG002', 'numSubjects': '936'}]}, {'type': 'DPPOS Phase 1 Primary', 'achievements': [{'comment': 'As reported in the Lancet 2009', 'groupId': 'FG000', 'numSubjects': '910'}, {'comment': 'As reported in the Lancet 2009', 'groupId': 'FG001', 'numSubjects': '924'}, {'comment': 'As reported in the Lancet 2009', 'groupId': 'FG002', 'numSubjects': '932'}]}, {'type': 'DPPOS Phase 2 Enrolled', 'achievements': [{'comment': 'As reported in Lancet Diabetes and Endocrinology 2015', 'groupId': 'FG000', 'numSubjects': '915'}, {'comment': 'As reported in Lancet Diabetes and Endocrinology 2015', 'groupId': 'FG001', 'numSubjects': '926'}, {'comment': 'As reported in Lancet Diabetes and Endocrinology 2015', 'groupId': 'FG002', 'numSubjects': '935'}]}, {'type': 'DPPOS Phase 2 Primary', 'achievements': [{'comment': 'As reported in Lancet Diabetes and Endocrinology 2015', 'groupId': 'FG000', 'numSubjects': '751'}, {'comment': 'As reported in Lancet Diabetes and Endocrinology 2015', 'groupId': 'FG001', 'numSubjects': '772'}, {'comment': 'As reported in Lancet Diabetes and Endocrinology 2015', 'groupId': 'FG002', 'numSubjects': '780'}]}, {'type': 'DPPOS Phase 3 Enrolled', 'comment': 'As of February 2016', 'achievements': [{'groupId': 'FG000', 'numSubjects': '916'}, {'groupId': 'FG001', 'numSubjects': '927'}, {'groupId': 'FG002', 'numSubjects': '936'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '916'}, {'groupId': 'FG001', 'numSubjects': '927'}, {'groupId': 'FG002', 'numSubjects': '936'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All surviving Diabetes Prevention Program (DPP) participants with consent were invited to enroll into DPPOS throughout the follow-up period. The majority of DPPOS participants were enrolled in 2002-2003.', 'preAssignmentDetails': 'DPPOS covers 3 funding phases for the 3 study phases: DPPOS-1 (2002-2008), DPPOS-2 (2009-2014), DPPOS-3 (2015-2021). The groups are defined using the original randomized groups from DPP with recruitment period of 1996-1998.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '916', 'groupId': 'BG000'}, {'value': '927', 'groupId': 'BG001'}, {'value': '936', 'groupId': 'BG002'}, {'value': '2779', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '1 Original Lifestyle', 'description': 'randomized to unmasked Intensive Lifestyle (ILS) during the DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle plus DPPOS Boost Lifestyle sessions in DPPOS Phase 1 and 2\n\nDPPOS Group Lifestyle: Quarterly group lifestyle sessions\n\nDPPOS Boost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.\n\nIntensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions'}, {'id': 'BG001', 'title': '2 Original Metformin', 'description': 'randomized to the masked metformin treatment group during DPP and continued open label in DPPOS. Participants were also offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2.\n\nDPPOS Group Lifestyle: Quarterly group lifestyle sessions\n\nMetformin: Administered as 850mg twice per day, masked in DPP and open label in DPPOS\n\nIntensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions'}, {'id': 'BG002', 'title': '3 Original Placebo', 'description': 'randomized to masked placebo during DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2\n\nDPPOS Group Lifestyle: Quarterly group lifestyle sessions\n\nIntensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '915', 'groupId': 'BG000'}, {'value': '927', 'groupId': 'BG001'}, {'value': '936', 'groupId': 'BG002'}, {'value': '2778', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '54', 'spread': '11', 'groupId': 'BG000'}, {'value': '54', 'spread': '10', 'groupId': 'BG001'}, {'value': '54', 'spread': '10', 'groupId': 'BG002'}, {'value': '54', 'spread': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'An additional 3 participants were enrolled after publication'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '916', 'groupId': 'BG000'}, {'value': '927', 'groupId': 'BG001'}, {'value': '936', 'groupId': 'BG002'}, {'value': '2779', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '51.2', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '51.3', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '50.7', 'spread': '10.0', 'groupId': 'BG002'}, {'value': '51.1', 'spread': '10.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '916', 'groupId': 'BG000'}, {'value': '927', 'groupId': 'BG001'}, {'value': '936', 'groupId': 'BG002'}, {'value': '2779', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '624', 'groupId': 'BG000'}, {'value': '620', 'groupId': 'BG001'}, {'value': '645', 'groupId': 'BG002'}, {'value': '1889', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '292', 'groupId': 'BG000'}, {'value': '307', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}, {'value': '890', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '916', 'groupId': 'BG000'}, {'value': '927', 'groupId': 'BG001'}, {'value': '936', 'groupId': 'BG002'}, {'value': '2779', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}, {'value': '544', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '596', 'groupId': 'BG000'}, {'value': '628', 'groupId': 'BG001'}, {'value': '612', 'groupId': 'BG002'}, {'value': '1836', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '916', 'groupId': 'BG000'}, {'value': '927', 'groupId': 'BG001'}, {'value': '936', 'groupId': 'BG002'}, {'value': '2779', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '916', 'groupId': 'BG000'}, {'value': '927', 'groupId': 'BG001'}, {'value': '936', 'groupId': 'BG002'}, {'value': '2779', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '916', 'groupId': 'BG000'}, {'value': '927', 'groupId': 'BG001'}, {'value': '936', 'groupId': 'BG002'}, {'value': '2779', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '33.7', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '33.8', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '34.0', 'spread': '6.5', 'groupId': 'BG002'}, {'value': '33.8', 'spread': '6.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-22', 'size': 1157567, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-20T12:11', 'hasProtocol': True}, {'date': '2017-11-27', 'size': 147554, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-07-17T17:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open label phase for metformin'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2779}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-03', 'studyFirstSubmitDate': '2002-06-04', 'resultsFirstSubmitDate': '2017-02-21', 'studyFirstSubmitQcDate': '2002-06-04', 'lastUpdatePostDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-25', 'studyFirstPostDateStruct': {'date': '2002-06-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of Diabetes.', 'timeFrame': 'Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).', 'description': 'Primary outcome for years 2002-2008 defined according to American Diabetes Association criteria (fasting plasma glucose level \\>= 126 mg/dL \\[7.0 mmol/L\\] or 2-hour plasma glucose \\>= 200 mg/dL \\[11.1 mmol/L\\], after a 75 gram oral glucose tolerance test (OGTT), and confirmed with a repeat test).'}, {'measure': 'Prevalence of Aggregate Microvascular Complication', 'timeFrame': 'Outcomes were assessed from 2012-2013 (approximately 2 years).', 'description': 'Aggregate microvascular disease is defined as the average prevalence of 3 components: (1) retinopathy measured by photography (ETDRS of 20 or greater); (2) neuropathy detected by Semmes Weinstein 10 gram monofilament, and (3) nephropathy based on estimated glomerular filtration rate (eGFR by chronic kidney disease (CKD-Epi) equation ) (\\<45 ml/min, confirmed) and albumin-to-creatinine ratio in spot urine (\\> 30mg/gm, confirmed).'}, {'measure': 'Total Cancer Except Non-melanoma Skin Cancer', 'timeFrame': 'Outcomes were assessed from 1996-2020 (approximately 24 years).', 'description': 'All primary incident cancers except non-melanoma skin cancer'}, {'measure': 'Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD)', 'timeFrame': 'Outcomes were assessed from 1996-2025 (approximately 29 years).', 'description': 'Defined as MI, stroke and CVD death. These outcomes were collected since randomization and adjudicated by an outcomes committee who are blinded to treatment assignment.'}], 'secondaryOutcomes': [{'measure': 'Subclinical Atherosclerosis', 'timeFrame': 'Outcomes were assessed from 2012-2013 (approximately 2 years).', 'description': 'Measured using coronary artery calcification (CAC).'}, {'measure': 'Cognitive Function', 'timeFrame': 'Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.', 'description': 'Cognitive function defined as a composite measure constructed from tests of memory (English Spanish Verbal Learning Test) and executive function (word fluency and Digit Symbol Substitution Test ).'}, {'measure': 'Short Physical Performance Battery', 'timeFrame': 'Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.', 'description': 'Physical function is measured using the short physical performance battery (SPPB), which is comprised of measures of 1) time to walk 3-4 meters, 2) balance, i.e., side-by-side stand, semi-tandem stand, and tandem stand, and 3) repeated chair stands.'}, {'measure': 'Frailty', 'timeFrame': 'Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.', 'description': 'Description: The Cardiovascular Health Study Frailty score is based on 5 frailty characteristics: slow walking speed, low energy expenditure, exhaustion, weak grip strength, and unintentional weight loss.'}, {'measure': 'Mortality', 'timeFrame': 'Outcomes were assessed throughout follow-up from 1996 to 2022. National Death Index search conducted in 2019 using early release data as of Dec 2018.', 'description': 'All cause-mortality through clinic reports and National Death Index search'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DPP', 'IGT', 'Prediabetes', 'Type 2 diabetes', 'Macrovascular disease', 'Microvascular disease', 'Lifestyle', 'Metformin', 'Obesity'], 'conditions': ['Diabetes Mellitus', 'Cancer', 'CVD']}, 'referencesModule': {'references': [{'pmid': '11832527', 'type': 'BACKGROUND', 'citation': 'Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.'}, {'pmid': '19878986', 'type': 'RESULT', 'citation': 'Diabetes Prevention Program Research Group; Knowler WC, Fowler SE, Hamman RF, Christophi CA, Hoffman HJ, Brenneman AT, Brown-Friday JO, Goldberg R, Venditti E, Nathan DM. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009 Nov 14;374(9702):1677-86. doi: 10.1016/S0140-6736(09)61457-4. Epub 2009 Oct 29.'}, {'pmid': '26377054', 'type': 'RESULT', 'citation': 'Diabetes Prevention Program Research Group. Long-term effects of lifestyle intervention or metformin on diabetes development and microvascular complications over 15-year follow-up: the Diabetes Prevention Program Outcomes Study. Lancet Diabetes Endocrinol. 2015 Nov;3(11):866-75. doi: 10.1016/S2213-8587(15)00291-0. Epub 2015 Sep 13.'}, {'pmid': '41413398', 'type': 'DERIVED', 'citation': 'Lin PD, Cardenas A, Temprosa M, Botelho JC, Calafat AM, Gold DR, Oken E, Fleisch AF. Associations of Perfluoroalkyl and Polyfluoroalkyl Substances With Cardiovascular Disease Incidence in Adults With Prediabetes: Findings From the Diabetes Prevention Program. J Am Heart Assoc. 2025 Dec 18:e046298. doi: 10.1161/JAHA.125.046298. Online ahead of print.'}, {'pmid': '40675492', 'type': 'DERIVED', 'citation': 'Tjaden AH, Goldbaum AA, Edelstein SL, Heckman-Stoddard BM, Reedy J, Herman WH, Hoskin M, Knowler WC, Schlogl M, Temple KA, Venditti EM, Watson K, Temprosa M, Shams-White MM; DPP Research Group. The 2018 World Cancer Research Fund/American Institute for Cancer Research Score and Cancer Risk: results from the diabetes prevention program outcomes study. Am J Clin Nutr. 2025 Sep;122(3):715-723. doi: 10.1016/j.ajcnut.2025.07.011. Epub 2025 Jul 15.'}, {'pmid': '40311647', 'type': 'DERIVED', 'citation': 'Knowler WC, Doherty L, Edelstein SL, Bennett PH, Dabelea D, Hoskin M, Kahn SE, Kalyani RR, Kim C, Pi-Sunyer FX, Raghavan S, Shah VO, Temprosa M, Venditti EM, Nathan DM; DPP/DPPOS Research Group. Long-term effects and effect heterogeneity of lifestyle and metformin interventions on type 2 diabetes incidence over 21 years in the US Diabetes Prevention Program randomised clinical trial. Lancet Diabetes Endocrinol. 2025 Jun;13(6):469-481. doi: 10.1016/S2213-8587(25)00022-1. Epub 2025 Apr 28.'}, {'pmid': '39744353', 'type': 'DERIVED', 'citation': 'Munshi MN, Venditti EM, Tjaden AH, Knowler WC, Boyko EJ, Middelbeek RJW, Luchsinger JA, Lee CG, Hazuda HP, Salive ME, Edelstein SL, Storer TW. Long-term impact of Diabetes Prevention Program interventions on walking endurance. Front Public Health. 2024 Dec 18;12:1470035. doi: 10.3389/fpubh.2024.1470035. eCollection 2024.'}, {'pmid': '37929764', 'type': 'DERIVED', 'citation': 'Gadde KM, Yin X, Goldberg RB, Orchard TJ, Schlogl M, Dabelea D, Ibebuogu UN, Watson KE, Pi-Sunyer FX, Crandall JP, Temprosa M, Luchsinger JA; Diabetes Prevention Program Research Group. Coronary Artery Calcium and Cognitive Decline in the Diabetes Prevention Program Outcomes Study. J Am Heart Assoc. 2023 Nov 7;12(21):e029671. doi: 10.1161/JAHA.123.029671. Epub 2023 Nov 6.'}, {'pmid': '37607422', 'type': 'DERIVED', 'citation': 'Molitch ME, Tripputi M, Levey AS, Crandall JP, Dabelea D, Herman WH, Knowler WC, Orchard TJ, Schroeder EB, Srikanthan P, Temprosa M, White NH, Nathan DM; Diabetes Prevention Program Research Group. Electronic address: dppmail@bsc.gwu.edu. Effects of metformin and intensive lifestyle interventions on the incidence of kidney disease in adults in the DPP/DPPOS. J Diabetes Complications. 2023 Sep;37(9):108556. doi: 10.1016/j.jdiacomp.2023.108556. Epub 2023 Jul 25.'}, {'pmid': '36131333', 'type': 'DERIVED', 'citation': 'Shams-White MM, Tjaden AH, Edelstein SL, Bassiouni S, Kahle LL, Kim C, Pi-Sunyer X, Temple KA, Venditti EM, Reedy J, Heckman-Stoddard BM; DPP Research Group. The 2018 World Cancer Research Fund (WCRF)/American Institute for Cancer Research (AICR) score and diabetes risk in the Diabetes Prevention Program Outcomes Study (DPPOS). BMC Nutr. 2022 Sep 21;8(1):105. doi: 10.1186/s40795-022-00596-7.'}, {'pmid': '35603600', 'type': 'DERIVED', 'citation': 'Goldberg RB, Orchard TJ, Crandall JP, Boyko EJ, Budoff M, Dabelea D, Gadde KM, Knowler WC, Lee CG, Nathan DM, Watson K, Temprosa M; Diabetes Prevention Program Research Group*. Effects of Long-term Metformin and Lifestyle Interventions on Cardiovascular Events in the Diabetes Prevention Program and Its Outcome Study. Circulation. 2022 May 31;145(22):1632-1641. doi: 10.1161/CIRCULATIONAHA.121.056756. Epub 2022 May 23.'}, {'pmid': '34697033', 'type': 'DERIVED', 'citation': 'Lee CG, Heckman-Stoddard B, Dabelea D, Gadde KM, Ehrmann D, Ford L, Prorok P, Boyko EJ, Pi-Sunyer X, Wallia A, Knowler WC, Crandall JP, Temprosa M; Diabetes Prevention Program Research Group; Diabetes Prevention Program Research Group:. Effect of Metformin and Lifestyle Interventions on Mortality in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study. Diabetes Care. 2021 Dec;44(12):2775-2782. doi: 10.2337/dc21-1046. Epub 2021 Oct 25.'}, {'pmid': '33789908', 'type': 'DERIVED', 'citation': 'Varga TV, Liu J, Goldberg RB, Chen G, Dagogo-Jack S, Lorenzo C, Mather KJ, Pi-Sunyer X, Brunak S, Temprosa M; Diabetes Prevention Program Research Group. Predictive utilities of lipid traits, lipoprotein subfractions and other risk factors for incident diabetes: a machine learning approach in the Diabetes Prevention Program. BMJ Open Diabetes Res Care. 2021 Mar;9(1):e001953. doi: 10.1136/bmjdrc-2020-001953.'}, {'pmid': '33444158', 'type': 'DERIVED', 'citation': 'Kriska AM, Rockette-Wagner B, Edelstein SL, Bray GA, Delahanty LM, Hoskin MA, Horton ES, Venditti EM, Knowler WC; DPP Research Group. The Impact of Physical Activity on the Prevention of Type 2 Diabetes: Evidence and Lessons Learned From the Diabetes Prevention Program, a Long-Standing Clinical Trial Incorporating Subjective and Objective Activity Measures. Diabetes Care. 2021 Jan;44(1):43-49. doi: 10.2337/dc20-1129. Epub 2020 Nov 10.'}, {'pmid': '33428709', 'type': 'DERIVED', 'citation': 'Hazuda HP, Pan Q, Florez H, Luchsinger JA, Crandall JP, Venditti EM, Golden SH, Kriska AM, Bray GA. Association of Intensive Lifestyle and Metformin Interventions With Frailty in the Diabetes Prevention Program Outcomes Study. J Gerontol A Biol Sci Med Sci. 2021 Apr 30;76(5):929-936. doi: 10.1093/gerona/glaa295.'}, {'pmid': '31955207', 'type': 'DERIVED', 'citation': 'Kim C, Younes N, Temprosa M, Edelstein S, Goldberg RB, Araneta MG, Wallia A, Brown A, Darwin C, Ibebuogu U, Pi-Sunyer X, Knowler WC. Infertility, Gravidity, and Risk Of Diabetes among High-Risk Women in the Diabetes Prevention Program Outcomes Study. J Clin Endocrinol Metab. 2020 Mar 1;105(3):e358-67. doi: 10.1210/clinem/dgaa013.'}, {'pmid': '31320445', 'type': 'DERIVED', 'citation': 'Perreault L, Pan Q, Schroeder EB, Kalyani RR, Bray GA, Dagogo-Jack S, White NH, Goldberg RB, Kahn SE, Knowler WC, Mathioudakis N, Dabelea D; Diabetes Prevention Program Research Group. Regression From Prediabetes to Normal Glucose Regulation and Prevalence of Microvascular Disease in the Diabetes Prevention Program Outcomes Study (DPPOS). Diabetes Care. 2019 Sep;42(9):1809-1815. doi: 10.2337/dc19-0244. Epub 2019 Jul 18.'}, {'pmid': '31296647', 'type': 'DERIVED', 'citation': 'Cardenas A, Hivert MF, Gold DR, Hauser R, Kleinman KP, Lin PD, Fleisch AF, Calafat AM, Ye X, Webster TF, Horton ES, Oken E. Associations of Perfluoroalkyl and Polyfluoroalkyl Substances With Incident Diabetes and Microvascular Disease. Diabetes Care. 2019 Sep;42(9):1824-1832. doi: 10.2337/dc18-2254. Epub 2019 Jul 11.'}, {'pmid': '31009939', 'type': 'DERIVED', 'citation': 'Apolzan JW, Venditti EM, Edelstein SL, Knowler WC, Dabelea D, Boyko EJ, Pi-Sunyer X, Kalyani RR, Franks PW, Srikanthan P, Gadde KM; Diabetes Prevention Program Research Group. Long-Term Weight Loss With Metformin or Lifestyle Intervention in the Diabetes Prevention Program Outcomes Study. Ann Intern Med. 2019 May 21;170(10):682-690. doi: 10.7326/M18-1605. Epub 2019 Apr 23.'}, {'pmid': '30877090', 'type': 'DERIVED', 'citation': 'Diabetes Prevention Program Research Group. Long-term Effects of Metformin on Diabetes Prevention: Identification of Subgroups That Benefited Most in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study. Diabetes Care. 2019 Apr;42(4):601-608. doi: 10.2337/dc18-1970.'}, {'pmid': '30646133', 'type': 'DERIVED', 'citation': 'Cardenas A, Hauser R, Gold DR, Kleinman KP, Hivert MF, Fleisch AF, Lin PD, Calafat AM, Webster TF, Horton ES, Oken E. Association of Perfluoroalkyl and Polyfluoroalkyl Substances With Adiposity. JAMA Netw Open. 2018 Aug 3;1(4):e181493. doi: 10.1001/jamanetworkopen.2018.1493.'}, {'pmid': '30398516', 'type': 'DERIVED', 'citation': 'Kim C, Ricardo AC, Boyko EJ, Christophi CA, Temprosa M, Watson KE, Pi-Sunyer X, Kalyani RR; Diabetes Prevention Program Research Group. Sex Hormones and Measures of Kidney Function in the Diabetes Prevention Program Outcomes Study. J Clin Endocrinol Metab. 2019 Apr 1;104(4):1171-1180. doi: 10.1210/jc.2018-01495.'}, {'pmid': '30275282', 'type': 'DERIVED', 'citation': 'DeBoer MD, Filipp SL, Gurka MJ. Use of a Metabolic Syndrome Severity Z Score to Track Risk During Treatment of Prediabetes: An Analysis of the Diabetes Prevention Program. Diabetes Care. 2018 Nov;41(11):2421-2430. doi: 10.2337/dc18-1079. Epub 2018 Oct 1.'}, {'pmid': '29220533', 'type': 'DERIVED', 'citation': 'Kim C, Aroda VR, Goldberg RB, Younes N, Edelstein SL, Carrion-Petersen M, Ehrmann DA; Diabetes Prevention Program Outcomes Study Group. Androgens, Irregular Menses, and Risk of Diabetes and Coronary Artery Calcification in the Diabetes Prevention Program. J Clin Endocrinol Metab. 2018 Feb 1;103(2):486-496. doi: 10.1210/jc.2017-01829.'}, {'pmid': '29081977', 'type': 'DERIVED', 'citation': 'Crandall JP, Mather K, Rajpathak SN, Goldberg RB, Watson K, Foo S, Ratner R, Barrett-Connor E, Temprosa M. Statin use and risk of developing diabetes: results from the Diabetes Prevention Program. BMJ Open Diabetes Res Care. 2017 Oct 10;5(1):e000438. doi: 10.1136/bmjdrc-2017-000438. eCollection 2017.'}, {'pmid': '28833481', 'type': 'DERIVED', 'citation': 'Perreault L, Pan Q, Aroda VR, Barrett-Connor E, Dabelea D, Dagogo-Jack S, Hamman RF, Kahn SE, Mather KJ, Knowler WC; Diabetes Prevention Program Research Group. Exploring residual risk for diabetes and microvascular disease in the Diabetes Prevention Program Outcomes Study (DPPOS). Diabet Med. 2017 Dec;34(12):1747-1755. doi: 10.1111/dme.13453. Epub 2017 Sep 19.'}, {'pmid': '28770322', 'type': 'DERIVED', 'citation': 'Aroda VR, Knowler WC, Crandall JP, Perreault L, Edelstein SL, Jeffries SL, Molitch ME, Pi-Sunyer X, Darwin C, Heckman-Stoddard BM, Temprosa M, Kahn SE, Nathan DM; Diabetes Prevention Program Research Group. Metformin for diabetes prevention: insights gained from the Diabetes Prevention Program/Diabetes Prevention Program Outcomes Study. Diabetologia. 2017 Sep;60(9):1601-1611. doi: 10.1007/s00125-017-4361-9. Epub 2017 Aug 2.'}, {'pmid': '28702228', 'type': 'DERIVED', 'citation': 'Herman WH. The cost-effectiveness of diabetes prevention: results from the Diabetes Prevention Program and the Diabetes Prevention Program Outcomes Study. Clin Diabetes Endocrinol. 2015 Sep 2;1:9. doi: 10.1186/s40842-015-0009-1. eCollection 2015.'}, {'pmid': '28651370', 'type': 'DERIVED', 'citation': 'Kim C, Dabelea D, Kalyani RR, Christophi CA, Bray GA, Pi-Sunyer X, Darwin CH, Yalamanchi S, Barrett-Connor E, Golden SH, Boyko EJ. Changes in Visceral Adiposity, Subcutaneous Adiposity, and Sex Hormones in the Diabetes Prevention Program. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3381-3389. doi: 10.1210/jc.2017-00967.'}, {'pmid': '28500216', 'type': 'DERIVED', 'citation': 'Luchsinger JA, Ma Y, Christophi CA, Florez H, Golden SH, Hazuda H, Crandall J, Venditti E, Watson K, Jeffries S, Manly JJ, Pi-Sunyer FX; Diabetes Prevention Program Research Group. Metformin, Lifestyle Intervention, and Cognition in the Diabetes Prevention Program Outcomes Study. Diabetes Care. 2017 Jul;40(7):958-965. doi: 10.2337/dc16-2376. Epub 2017 May 12.'}, {'pmid': '28476766', 'type': 'DERIVED', 'citation': 'Goldberg RB, Aroda VR, Bluemke DA, Barrett-Connor E, Budoff M, Crandall JP, Dabelea D, Horton ES, Mather KJ, Orchard TJ, Schade D, Watson K, Temprosa M; Diabetes Prevention Program Research Group. Effect of Long-Term Metformin and Lifestyle in the Diabetes Prevention Program and Its Outcome Study on Coronary Artery Calcium. Circulation. 2017 Jul 4;136(1):52-64. doi: 10.1161/CIRCULATIONAHA.116.025483. Epub 2017 May 5.'}, {'pmid': '26900641', 'type': 'DERIVED', 'citation': 'Aroda VR, Edelstein SL, Goldberg RB, Knowler WC, Marcovina SM, Orchard TJ, Bray GA, Schade DS, Temprosa MG, White NH, Crandall JP; Diabetes Prevention Program Research Group. Long-term Metformin Use and Vitamin B12 Deficiency in the Diabetes Prevention Program Outcomes Study. J Clin Endocrinol Metab. 2016 Apr;101(4):1754-61. doi: 10.1210/jc.2015-3754. Epub 2016 Feb 22.'}, {'pmid': '25775165', 'type': 'DERIVED', 'citation': 'Marrero DG, Ma Y, de Groot M, Horton ES, Price DW, Barrett-Connor E, Carnethon MR, Knowler WC; Diabetes Prevention Program Research Group. Depressive symptoms, antidepressant medication use, and new onset of diabetes in participants of the diabetes prevention program and the diabetes prevention program outcomes study. Psychosom Med. 2015 Apr;77(3):303-10. doi: 10.1097/PSY.0000000000000156.'}, {'pmid': '25706240', 'type': 'DERIVED', 'citation': 'Aroda VR, Christophi CA, Edelstein SL, Zhang P, Herman WH, Barrett-Connor E, Delahanty LM, Montez MG, Ackermann RT, Zhuo X, Knowler WC, Ratner RE; Diabetes Prevention Program Research Group. The effect of lifestyle intervention and metformin on preventing or delaying diabetes among women with and without gestational diabetes: the Diabetes Prevention Program outcomes study 10-year follow-up. J Clin Endocrinol Metab. 2015 Apr;100(4):1646-53. doi: 10.1210/jc.2014-3761. Epub 2015 Feb 23.'}, {'pmid': '25336746', 'type': 'DERIVED', 'citation': 'Diabetes Prevention Program Research Group. HbA1c as a predictor of diabetes and as an outcome in the diabetes prevention program: a randomized clinical trial. Diabetes Care. 2015 Jan;38(1):51-8. doi: 10.2337/dc14-0886. Epub 2014 Oct 21.'}, {'pmid': '25277389', 'type': 'DERIVED', 'citation': 'Diabetes Prevention Program (DPP) Research Group; Hamman RF, Horton E, Barrett-Connor E, Bray GA, Christophi CA, Crandall J, Florez JC, Fowler S, Goldberg R, Kahn SE, Knowler WC, Lachin JM, Murphy MB, Venditti E. Factors affecting the decline in incidence of diabetes in the Diabetes Prevention Program Outcomes Study (DPPOS). Diabetes. 2015 Mar;64(3):989-98. doi: 10.2337/db14-0333. Epub 2014 Oct 2.'}, {'pmid': '24646311', 'type': 'DERIVED', 'citation': 'Dabelea D, Ma Y, Knowler WC, Marcovina S, Saudek CD, Arakaki R, White NH, Kahn SE, Orchard TJ, Goldberg R, Palmer J, Hamman RF; Diabetes Prevention Program Research Group. Diabetes autoantibodies do not predict progression to diabetes in adults: the Diabetes Prevention Program. Diabet Med. 2014 Sep;31(9):1064-8. doi: 10.1111/dme.12437. Epub 2014 Apr 9.'}, {'pmid': '23709097', 'type': 'DERIVED', 'citation': 'Marrero D, Pan Q, Barrett-Connor E, de Groot M, Zhang P, Percy C, Florez H, Ackermann R, Montez M, Rubin RR; DPPOS Research Group. Impact of diagnosis of diabetes on health-related quality of life among high risk individuals: the Diabetes Prevention Program outcomes study. Qual Life Res. 2014 Feb;23(1):75-88. doi: 10.1007/s11136-013-0436-3. Epub 2013 May 26.'}, {'pmid': '23002085', 'type': 'DERIVED', 'citation': 'Price DW, Ma Y, Rubin RR, Perreault L, Bray GA, Marrero D, Knowler WC, Barrett-Connor E, Lacoursiere DY; Diabetes Prevention Program Research Group. Depression as a predictor of weight regain among successful weight losers in the diabetes prevention program. Diabetes Care. 2013 Feb;36(2):216-21. doi: 10.2337/dc12-0293. Epub 2012 Sep 21.'}, {'pmid': '22812594', 'type': 'DERIVED', 'citation': 'Diabetes Prevention Program Outcomes Study Research Group; Orchard TJ, Temprosa M, Barrett-Connor E, Fowler SE, Goldberg RB, Mather KJ, Marcovina SM, Montez M, Ratner RE, Saudek CD, Sherif H, Watson KE. Long-term effects of the Diabetes Prevention Program interventions on cardiovascular risk factors: a report from the DPP Outcomes Study. Diabet Med. 2013 Jan;30(1):46-55. doi: 10.1111/j.1464-5491.2012.03750.x.'}, {'pmid': '22683134', 'type': 'DERIVED', 'citation': 'Perreault L, Pan Q, Mather KJ, Watson KE, Hamman RF, Kahn SE; Diabetes Prevention Program Research Group. Effect of regression from prediabetes to normal glucose regulation on long-term reduction in diabetes risk: results from the Diabetes Prevention Program Outcomes Study. Lancet. 2012 Jun 16;379(9833):2243-51. doi: 10.1016/S0140-6736(12)60525-X. Epub 2012 Jun 9.'}, {'pmid': '22443353', 'type': 'DERIVED', 'citation': 'Mather KJ, Christophi CA, Jablonski KA, Knowler WC, Goldberg RB, Kahn SE, Spector T, Dastani Z, Waterworth D, Richards JB, Funahashi T, Pi-Sunyer FX, Pollin TI, Florez JC, Franks PW; Diabetes Prevention Program Research Group. Common variants in genes encoding adiponectin (ADIPOQ) and its receptors (ADIPOR1/2), adiponectin concentrations, and diabetes incidence in the Diabetes Prevention Program. Diabet Med. 2012 Dec;29(12):1579-88. doi: 10.1111/j.1464-5491.2012.03662.x.'}, {'pmid': '22442396', 'type': 'DERIVED', 'citation': 'Diabetes Prevention Program Research Group. Long-term safety, tolerability, and weight loss associated with metformin in the Diabetes Prevention Program Outcomes Study. Diabetes Care. 2012 Apr;35(4):731-7. doi: 10.2337/dc11-1299.'}, {'pmid': '22442395', 'type': 'DERIVED', 'citation': 'Diabetes Prevention Program Research Group. The 10-year cost-effectiveness of lifestyle intervention or metformin for diabetes prevention: an intent-to-treat analysis of the DPP/DPPOS. Diabetes Care. 2012 Apr;35(4):723-30. doi: 10.2337/dc11-1468.'}, {'pmid': '20805256', 'type': 'DERIVED', 'citation': 'Rubin RR, Ma Y, Peyrot M, Marrero DG, Price DW, Barrett-Connor E, Knowler WC; Diabetes Prevention Program Research Group. Antidepressant medicine use and risk of developing diabetes during the diabetes prevention program and diabetes prevention program outcomes study. Diabetes Care. 2010 Dec;33(12):2549-51. doi: 10.2337/dc10-1033. Epub 2010 Aug 30.'}, {'pmid': '19640960', 'type': 'DERIVED', 'citation': 'Crandall JP, Polsky S, Howard AA, Perreault L, Bray GA, Barrett-Connor E, Brown-Friday J, Whittington T, Foo S, Ma Y, Edelstein SL; Diabetes Prevention Program Research Group. Alcohol consumption and diabetes risk in the Diabetes Prevention Program. Am J Clin Nutr. 2009 Sep;90(3):595-601. doi: 10.3945/ajcn.2008.27382. Epub 2009 Jul 29.'}], 'seeAlsoLinks': [{'url': 'http://www.dppos.org', 'label': 'Study website'}, {'url': 'http://clinicaltrials.gov/ct2/show/NCT00004992', 'label': 'Clinical trials.gov entry for DPP'}]}, 'descriptionModule': {'briefSummary': 'The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT, 2 hour glucose of 140-199 mg/dl). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%.\n\nDPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest at risk population ever studied. Clinically important research questions remain that focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations.\n\nThe major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study retention and adherence (\\~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import.', 'detailedDescription': 'The current DPPOS Executive Summary and protocol, as well as DPPOS protocol and lifestyle manuals and publications are available at: http://www.dppos.org'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Participation as a volunteer in the Diabetes Prevention Program (DPP).'}, 'identificationModule': {'nctId': 'NCT00038727', 'acronym': 'DPPOS', 'briefTitle': 'Diabetes Prevention Program Outcomes Study', 'nctIdAliases': ['NCT00353314'], 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Diabetes Prevention Program Outcomes Study', 'orgStudyIdInfo': {'id': 'DPPOS'}, 'secondaryIdInfos': [{'id': 'U01DK048489', 'link': 'https://reporter.nih.gov/quickSearch/U01DK048489', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 Original Lifestyle', 'description': 'randomized to unmasked Intensive Lifestyle during the DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle plus DPPOS Boost Lifestyle sessions in DPPOS Phase 1 and 2', 'interventionNames': ['Behavioral: DPPOS Group Lifestyle', 'Behavioral: DPPOS Boost Lifestyle', 'Behavioral: Intensive Lifestyle Group Session']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 Original Metformin', 'description': 'randomized to the masked metformin treatment group during DPP and continued open label in DPPOS. Participants were also offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2.', 'interventionNames': ['Behavioral: DPPOS Group Lifestyle', 'Drug: Metformin', 'Behavioral: Intensive Lifestyle Group Session']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3 Original Placebo', 'description': 'randomized to masked placebo during DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2', 'interventionNames': ['Behavioral: DPPOS Group Lifestyle', 'Behavioral: Intensive Lifestyle Group Session']}], 'interventions': [{'name': 'DPPOS Group Lifestyle', 'type': 'BEHAVIORAL', 'description': 'Quarterly group lifestyle sessions', 'armGroupLabels': ['1 Original Lifestyle', '2 Original Metformin', '3 Original Placebo']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage'], 'description': 'Administered as 850mg twice per day, masked in DPP and open label in DPPOS', 'armGroupLabels': ['2 Original Metformin']}, {'name': 'DPPOS Boost Lifestyle', 'type': 'BEHAVIORAL', 'description': 'In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.', 'armGroupLabels': ['1 Original Lifestyle']}, {'name': 'Intensive Lifestyle Group Session', 'type': 'BEHAVIORAL', 'otherNames': ['Intensive lifestyle session (ILS)'], 'description': '16 session curriculum in group format. In DPP delivered to ILS as individual sessions', 'armGroupLabels': ['1 Original Lifestyle', '2 Original Metformin', '3 Original Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'George Washington University', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}], 'overallOfficials': [{'name': 'David M. Nathan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Marinella Temprosa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'George Washington University Biostatistics Center'}, {'name': 'Barbara Linder, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NIDDK Project Scientist'}, {'name': 'Kishore Gadde, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}, {'name': 'David Ehrmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}, {'name': 'Kevin Furlong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jefferson Medical College of Thomas Jefferson University'}, {'name': 'Kathleen Jablonski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'George Washington University Biostatistics Center'}, {'name': 'Ronald B Goldberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}, {'name': 'Helen P Hazuda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center at San Antonio'}, {'name': 'Dana Dabelea, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Medha Munshi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Joslin Diabetes Center'}, {'name': 'Steven Kahn, MB, ChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Samuel Dagogo-Jack, MD, MB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tennessee'}, {'name': 'Mark Molitch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}, {'name': 'Happy Araneta, PhD,MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}, {'name': 'F. Xavier Pi-Sunyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Kieren J Mather, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}, {'name': 'Michelle Magee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medstar Health Research Institute'}, {'name': 'Karol E Watson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}, {'name': 'Angela Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}, {'name': 'Sherita Hill Golden, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins School of Medicine'}, {'name': 'David S Schade, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of New Mexico'}, {'name': 'Jill Crandall, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}, {'name': 'Elizabeth Venditti, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Marjerie Mau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Hawaii'}, {'name': 'William Knowler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SW Indian Center, NIDDK'}, {'name': 'Santica M Marcovina, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'David M Nathan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Christine Lee, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NIDDK Project Scientist'}, {'name': 'Sunder Mudaliar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'ipdSharingStatementModule': {'url': 'https://repository.niddk.nih.gov/studies/dppos/', 'timeFrame': '2002-2025', 'ipdSharing': 'YES', 'description': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Repository', 'accessCriteria': 'Instructions for access are detailed here: https://repository.niddk.nih.gov/pages/overall\\_instructions/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'National Eye Institute (NEI)', 'class': 'NIH'}, {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}, {'name': "Office of Research on Women's Health (ORWH)", 'class': 'NIH'}, {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, {'name': 'American Diabetes Association', 'class': 'OTHER'}, {'name': 'Indian Health Service (IHS)', 'class': 'FED'}, {'name': 'General Clinical Research Program', 'class': 'UNKNOWN'}, {'name': 'US Department of Veterans Affairs', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}