Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-01-10 @ 2:49 PM
Study NCT ID:
NCT01612858
Status:
COMPLETED
Last Update Posted:
2016-06-20
First Post:
2012-06-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Metabolic Abnormalities in HIV-infected Persons
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008060', 'term': 'Lipodystrophy'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D012875', 'term': 'Skin Diseases, Metabolic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rkohli@tuftsmedicalcenter.org', 'phone': '617-636-4709', 'title': 'Rakhi Kohli MD MS', 'organization': 'Tufts Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for three months.', 'eventGroups': [{'id': 'EG000', 'title': 'Metformin', 'description': 'Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.', 'otherNumAtRisk': 16, 'otherNumAffected': 4, 'seriousNumAtRisk': 16, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Pioglitazone', 'description': 'Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.', 'otherNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': "Baker's cyst", 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'tooth pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}], 'seriousEvents': [{'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Elevated serum creatinine', 'notes': 'Two subjects experienced asymptomatic elevation in serum creatinine within 1.5 times the upper limit of normal.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Elevated lactic acid', 'notes': 'Two subjects developed asymptomatic elevation in lactic acid between 1.5 and 2 times the upper limit of normal.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Right upper quadrant abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Head trauma accompanied by syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.'}, {'id': 'OG001', 'title': 'Pioglitazone', 'description': 'Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.25', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '-0.96', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Change in insulin sensitivity measured by 2 hour euglycemic-hyperinsulinemic clamp from baseline to week 12 post treatment with metformin or pioglitazone', 'unitOfMeasure': 'mg/kg lean body mass/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with baseline and post insulin-sensitizing treatment euglycemic-hyperinsulinemic clamp were included in this analysis'}, {'type': 'SECONDARY', 'title': 'Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.'}, {'id': 'OG001', 'title': 'Pioglitazone', 'description': 'Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.30', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '-2.56', 'spread': '1.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Change in hepatic fat was measured after 12 weeks of treatment with metformin or pioglitazone using magnetic resonance spectroscopy', 'unitOfMeasure': 'percentage of hepatic fat', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with baseline and post insulin sensitizing treatment magnetic resonance spectrosocpy were included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metformin', 'description': 'Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.'}, {'id': 'FG001', 'title': 'Pioglitazone', 'description': 'Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Metformin', 'description': 'Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.'}, {'id': 'BG001', 'title': 'Pioglitazone', 'description': 'Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.9', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '55.7', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '54.2', 'spread': '7.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-12', 'studyFirstSubmitDate': '2012-06-04', 'resultsFirstSubmitDate': '2016-05-12', 'studyFirstSubmitQcDate': '2012-06-05', 'lastUpdatePostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-12', 'studyFirstPostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent', 'timeFrame': '3 months', 'description': 'Change in insulin sensitivity measured by 2 hour euglycemic-hyperinsulinemic clamp from baseline to week 12 post treatment with metformin or pioglitazone'}], 'secondaryOutcomes': [{'measure': 'Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent', 'timeFrame': '12 weeks', 'description': 'Change in hepatic fat was measured after 12 weeks of treatment with metformin or pioglitazone using magnetic resonance spectroscopy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lipodystrophy', 'Insulin resistance', 'HIV infection'], 'conditions': ['Lipodystrophy', 'HIV Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the relationship between insulin resistance and changes in body fat distribution in HIV-infected persons. This study measures insulin sensitivity, abdominal fat, and intramuscular fat in HIV-infected persons and examines the effect of an anti-diabetic drug (metformin or pioglitazone) on insulin sensitivity and body fat in this population.', 'detailedDescription': 'Although HIV antiretroviral medications have helped patients live longer, they have also been associated with side effects including insulin resistance and changes in body fat distribution. Changes in body fat distribution associated with HIV antiretroviral medications may result in increased fat in the abdomen, neck, and upper back, which is often called central fat deposition. HIV antiretroviral medications may also result in loss of fat in legs, arms, and face, which is often called peripheral fat atrophy.\n\nThis study will obtain preliminary data on the effect of 12 weeks of metformin on insulin sensitivity and hepatic and peripheral muscle fat in HIV-infected persons with insulin resistance and central fat deposition. Similarly, this study will obtain preliminary data on the effect of 12 weeks of pioglitazone on insulin sensitivity and hepatic and peripheral muscle fat in HIV-infected persons with insulin resistance and peripheral fat atrophy.\n\nThis study involves taking a drug that has been approved by the U.S. Food and Drug Administration (FDA) for use in humans for a period of 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-70 years\n* Fasting insulin \\>12 μU/mL and/or serum glucose between 140-200 mg/dl after 75 g 2hr oral glucose tolerance test\n* Central fat deposition or Peripheral fat atrophy\n* Fasting glucose ≤126 mg/dL\n* BMI ≥18 and ≤35 kg/m2\n* CD4 cell count ≥100 cells/mm3\n* Stable antiretroviral regimen ≥12 weeks and HIV RNA \\<1000 copies\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Cardiac pacemaker or metal implant\n* Liver enzymes \\>2.5x upper normal limit\n* Alkaline phosphatase or prothrombin time \\>2x upper normal limit\n* Serum creatinine \\>1.4 mg/dL\n* History of congestive heart failure\n* Hemoglobin \\<8 g/dL\n* Alcohol abuse\n* Pregnancy\n* History of lactic acidosis\n* Use of steroids\n* Acute infection within last one month\n* History of bladder cancer'}, 'identificationModule': {'nctId': 'NCT01612858', 'briefTitle': 'Metabolic Abnormalities in HIV-infected Persons', 'organization': {'class': 'OTHER', 'fullName': 'Tufts Medical Center'}, 'officialTitle': 'Metabolic Abnormalities in HIV-infected Persons', 'orgStudyIdInfo': {'id': 'CLAMP-K23'}, 'secondaryIdInfos': [{'id': '1K23DK079789-01A2', 'link': 'https://reporter.nih.gov/quickSearch/1K23DK079789-01A2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin', 'interventionNames': ['Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Pioglitazone', 'interventionNames': ['Drug: Pioglitazone']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Fortamet', 'Glucophage', 'Glumetza', 'Riomet'], 'description': 'Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.', 'armGroupLabels': ['Metformin']}, {'name': 'Pioglitazone', 'type': 'DRUG', 'otherNames': ['Actos'], 'description': 'Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.', 'armGroupLabels': ['Pioglitazone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Rakhi Kohli, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}