Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-21 @ 12:23 PM
Study NCT ID:
NCT02680457
Status:
COMPLETED
Last Update Posted:
2020-09-28
First Post:
2015-12-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571886', 'term': 'insulin degludec'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'uiec@prodigy.net.mx', 'phone': '+52 3310585200', 'title': 'Dr. Manuel González Ortiz', 'phoneExt': '34212', 'organization': 'Instituto de Terapéutica Experimental y Clínica, Universidad de Guadalajara'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'There were technical problems with the measurement of the outcomes. Design errors and protocol violations were detected at the end of the study. Therefore, the results are considered unreliable.'}}, 'adverseEventsModule': {'timeFrame': 'From the beginning of the study until a month after the end of the intervention for each patient, an average of 2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Insulin Degludec', 'description': 'Patients with Type 2 Diabetes mellitus\n\nInsulin Degludec: 10 IU SC every 24 hours for 6 days', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Insulin Glargine', 'description': 'Patients with Type 2 Diabetes mellitus\n\nInsulin Glargine: 10 IU SC every 24 hours for 6 days', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 9, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower limb paresthesias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glycemic Variability: Mean Amplitude of Glucose Excursion (MAGE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec', 'description': 'Patients who received:\n\nInsulin Degludec: 10 IU SC every 24 hours for 6 days, from both arms of the study'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Patients who received:\n\nInsulin Glargine: 10 IU SC every 24 hours for 6 days, from both arms of the study'}], 'classes': [{'categories': [{'measurements': [{'value': '75.2', 'spread': '38.9', 'groupId': 'OG000'}, {'value': '68.5', 'spread': '47.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.630', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 days', 'description': 'Mean amplitude of interstitial glucose excursions (MAGE) during the last 48 h of the ambulatory continuous glucose monitoring of 3 days (Guardian®, Medtronic MiniMed, Northridge); starting in the day 3 of the administration of insulin degludec or glargine', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparison between both interventions. There are not baseline values of this measurements due to a design error. There were technical problems with the measurements.'}, {'type': 'SECONDARY', 'title': 'Glycemic Variability: Area Under the Curve of Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec', 'description': 'Patients who received:\n\nInsulin Degludec: 10 IU SC every 24 hours for 6 days, from both arms of the study'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Patients who received:\n\nInsulin Glargine: 10 IU SC every 24 hours for 6 days, from both arms of the study'}], 'classes': [{'categories': [{'measurements': [{'value': '46776', 'spread': '17860', 'groupId': 'OG000'}, {'value': '46499', 'spread': '16971', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Every 5 min for 24 hours on day 5 post-dose', 'description': 'Area under the curve of glucose of the second day of continuous ambulatory glucose monitoring of 3 days (Guardian®, Medtronic MiniMed, Northridge)', 'unitOfMeasure': 'mg*h/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Area Under the Curve of Glucose in a patient (Insulin Degludec group) could not be calculated. There are not baseline values of this measurements due to a design error. There were technical problems with the measurements.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Degludec - Insulin Glargine', 'description': 'Insulin Degludec: 10 IU subcutaneous (SC) every 24 hours for 6 days Washout period for 14 days Insulin Glargine 10 IU SC every 24 hours for 6 days'}, {'id': 'FG001', 'title': 'Insulin Glargine - Insulin Degludec', 'description': 'Insulin Glargine: 10 IU subcutaneous (SC) every 24 hours for 6 days Washout period for 14 days Insulin Degludec 10 IU SC every 24 hours for 6 days'}], 'periods': [{'title': 'Initial Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Cross-over Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Total number of patients: 12 in a crossover intervention. Interventions: 2. Washout period before the cross-over intervention. Protocol violations were detected at the end of the study in patients of both groups'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Total Group', 'description': 'Total Group of Patients with Type 2 Diabetes mellitus'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.1', 'spread': '8.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '80.5', 'spread': '13.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '32.1', 'spread': '2.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '114.8', 'spread': '8.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '75.8', 'spread': '6.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin A1c', 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '1.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% of Hemoglobin A1c', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Plasma Glucose', 'classes': [{'categories': [{'measurements': [{'value': '181', 'spread': '59.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Uric Acid', 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '1.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Creatinine', 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '174.8', 'spread': '29.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High-density lipoprotein-cholesterol (HDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '42.3', 'spread': '9.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Low-density lipoprotein-cholesterol (LDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '92.6', 'spread': '27.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '199.3', 'spread': '84.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aspartate aminotransferase (AST)', 'classes': [{'categories': [{'measurements': [{'value': '25.8', 'spread': '11.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Alanine aminotransferase (ALT)', 'classes': [{'categories': [{'measurements': [{'value': '41.6', 'spread': '25.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Characteristics of the entire group'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-25', 'studyFirstSubmitDate': '2015-12-07', 'resultsFirstSubmitDate': '2020-08-16', 'studyFirstSubmitQcDate': '2016-02-10', 'lastUpdatePostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-25', 'studyFirstPostDateStruct': {'date': '2016-02-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic Variability: Mean Amplitude of Glucose Excursion (MAGE)', 'timeFrame': '2 days', 'description': 'Mean amplitude of interstitial glucose excursions (MAGE) during the last 48 h of the ambulatory continuous glucose monitoring of 3 days (Guardian®, Medtronic MiniMed, Northridge); starting in the day 3 of the administration of insulin degludec or glargine'}], 'secondaryOutcomes': [{'measure': 'Glycemic Variability: Area Under the Curve of Glucose', 'timeFrame': 'Every 5 min for 24 hours on day 5 post-dose', 'description': 'Area under the curve of glucose of the second day of continuous ambulatory glucose monitoring of 3 days (Guardian®, Medtronic MiniMed, Northridge)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Type 2 diabetes mellitus (T2DM) is characterized by wide fluctuations of glucose. The long-acting insulin has showed to improve glycemic variability however the behavior of insulin glargine versus insulin degludec is unknown.', 'detailedDescription': 'Cross-over, double dummy, randomized, clinical trial was carried out. The sample size was calculated using the formula for clinical trials of mean differences with an "n" of 6 patients per group was obtained. Patients between 30 and 65 years of age will be included with T2DM, without hyperglycemic drugs, hemoglobin A1c (A1C) 6.5 to 11.0 % and with written signature consent. They were assigned randomly by sealed envelope either to received insulin Degludec (Novo Nordisk A/S. Bagsvaerd, Denmark) or insulin Glargine (Sanofi-Aventis Deutschland GmbH. Frankfurt, Germany) \\[10 international units (IU) subcutaneous (SC) every 24 hours for six days\\], patients who were administered initially insulin Degludec corresponded then insulin Glargine and vice versa, with a washout period of 14 days between each intervention.\n\nThe clinical findings and laboratory tests included a metabolic profile and biosafety, which will be made at baseline. Body weight, body mass index and blood pressure were performed during the initial visit, likewise, interstitial glucose concentrations by ambulatory continuous glucose monitoring system (Guardian®, Medtronic MiniMed, Northridge), through which the mean amplitude of glucose excursions (MAGE) and area under the curve of glucose were calculated, which served to assess the glycemic variability. Adverse events and adherence to treatment are documented. Statistical analysis: Mann-Whitney U test, Chi2, Fisher exact test. It is considered with significance at p \\<0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with T2DM without treatment for at least 3 months Body mass index (BMI) from 25.0-34.9 kg/m2 Diagnosis of T2DM\n* Fasting plasma glucose ≤300 mg/dL at the time of scrutiny\n* A1C between 6.5 and 11%\n* Written informed consent\n\nExclusion Criteria:\n\n* Women pregnant or breastfeeding\n* Untreated thyroid disease and/or uncontrolled hypertension \\[≥150 systolic and diastolic ≥90\\]\n* Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose. In the case of antihypertensives, these may be included if treatment was not modified previous 3 months and no change during the study.\n* Total cholesterol \\>240 mg/dL\n* Triglycerides ≥400 mg/dL\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than twice the normal range\n* Glomerular filtration rate \\<60 mL/min \\[Cockcroft-Gault\\]'}, 'identificationModule': {'nctId': 'NCT02680457', 'acronym': 'Diabetes', 'briefTitle': 'Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Guadalajara'}, 'officialTitle': 'Effect of the Administration of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus Drug-naïve', 'orgStudyIdInfo': {'id': 'CT-DG-140282-JLRN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Degludec - Insulin Glargine', 'description': 'Insulin Degludec 10 IU SC every 24 hours for 6 days Washout for 14 days Insulin Glargine 10 IU SC every 24 hours for 6 days', 'interventionNames': ['Drug: Insulin Degludec', 'Drug: Insulin Glargine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Glargine - Insulin Degludec', 'description': 'Insulin Glargine 10 IU SC every 24 hours for 6 days Washout for 14 days Insulin Degludec 10 IU SC every 24 hours for 6 days', 'interventionNames': ['Drug: Insulin Degludec', 'Drug: Insulin Glargine']}], 'interventions': [{'name': 'Insulin Degludec', 'type': 'DRUG', 'otherNames': ['Tresiba ® (Novo Nordisk A/S. Bagsvaerd, Denmark)'], 'description': 'Insulin Degludec 10 IU SC every 24 hours for 6 days', 'armGroupLabels': ['Insulin Degludec - Insulin Glargine', 'Insulin Glargine - Insulin Degludec']}, {'name': 'Insulin Glargine', 'type': 'DRUG', 'otherNames': ['Lantus ® (Sanofi-Aventis Deutschland GmbH. Frankfurt, Germany)'], 'description': 'Insulin Glargine 10 IU SC every 24 hours for 6 days', 'armGroupLabels': ['Insulin Degludec - Insulin Glargine', 'Insulin Glargine - Insulin Degludec']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44340', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'overallOfficials': [{'name': 'MANUEL GONZALEZ, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guadalajara'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guadalajara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Manuel González Ortiz', 'investigatorAffiliation': 'University of Guadalajara'}}}}