Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT00413335
Status:
COMPLETED
Last Update Posted:
2013-07-22
First Post:
2006-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077154', 'term': 'Rosiglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Sonia.Caprio@yale.edu', 'phone': '203-785-5692', 'title': 'Dr. Sonia Caprio, Principal Investigator', 'organization': 'Yale University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Active Arm (Rosiglitazone)', 'description': 'Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.\n\nRosiglitazone : 2mg to begin then 4mg, twice daily for 4 months', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Inactive Arm (Placebo)', 'description': 'Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.\n\nPlacebo : Subject receives placebo.', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Percent Change From Baseline in Whole-body Insulin Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm (Rosiglitazone)', 'description': 'Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.\n\nRosiglitazone : 2mg to begin then 4mg, twice daily for 4 months'}, {'id': 'OG001', 'title': 'Inactive Arm (Placebo)', 'description': 'Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.\n\nPlacebo : Subject receives placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.4', 'spread': '77.0', 'groupId': 'OG000'}, {'value': '63.1', 'spread': '61.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'This describes the percent changes in insulin sensitivity. Insulin sensitivity was expressed as whole body insulin sensitivity index (WBISI) which is based on the values of insulin (microunits per milliliter) and glucose (milligrams per deciliter) obtained from the OGTT and the corresponding fasting values.The formula is: WBISI=10.000/square root of (fasting glucose x fasting insulin)x(mean glucose x mean insulin).', 'unitOfMeasure': 'percentage of change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm (Rosiglitazone)', 'description': 'Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.\n\nRosiglitazone : 2mg to begin then 4mg, twice daily for 4 months'}, {'id': 'OG001', 'title': 'Inactive Arm (Placebo)', 'description': 'Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.\n\nPlacebo : Subject receives placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.3', 'spread': '23.1', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '22.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'This describes the percent changes of the ratio between visceral and subcutaneous abdominal fat.', 'unitOfMeasure': 'percentage of change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm (Rosiglitazone)', 'description': 'Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.\n\nRosiglitazone : 2mg to begin then 4mg, twice daily for 4 months'}, {'id': 'OG001', 'title': 'Inactive Arm (Placebo)', 'description': 'Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.\n\nPlacebo : Subject receives placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 months', 'description': 'This refers to the number of subjects that converted from IGT to NGT. NGT is defined as fasting glucose lower than 100 mg/dl and 2 hours glucose lower than 140 mg/dl. IGT is defined as 2 hours glucose higher than 140 mg/dl.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in Adiponectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm (Rosiglitazone)', 'description': 'Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.\n\nRosiglitazone : 2mg to begin then 4mg, twice daily for 4 months'}, {'id': 'OG001', 'title': 'Inactive Arm (Placebo)', 'description': 'Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.\n\nPlacebo : Subject receives placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.3', 'spread': '78.2', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '52.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'This refers to the changes of adiponectin levels.', 'unitOfMeasure': 'percentage of change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm (Rosiglitazone)', 'description': 'Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.\n\nRosiglitazone : 2mg to begin then 4mg, twice daily for 4 months'}, {'id': 'OG001', 'title': 'Inactive Arm (Placebo)', 'description': 'Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.\n\nPlacebo : Subject receives placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '107', 'groupId': 'OG000'}, {'value': '81', 'spread': '267', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'It refers to the percent changes of hepatic fat content.', 'unitOfMeasure': 'percentage of change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Arm (Rosiglitazone)', 'description': 'Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.\n\nRosiglitazone : 2mg to begin then 4mg, twice daily for 4 months'}, {'id': 'FG001', 'title': 'Inactive Arm (Placebo)', 'description': 'Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.\n\nPlacebo : Subject receives placebo.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from a multi-ethnic cohort of obese children and adolescents drawn from the Pediatric Obesity Clinic at Yale-New Haven Hospital.', 'preAssignmentDetails': 'Obese children and adolescents with positive risk factors for Type 2 Diabetes (T2DM) were screened by using a standard oral glucose tolerance test (OCTT).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Arm (Rosiglitazone)', 'description': 'Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.\n\nRosiglitazone : 2mg to begin then 4mg, twice daily for 4 months'}, {'id': 'BG001', 'title': 'Inactive Arm (Placebo)', 'description': 'Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.\n\nPlacebo : Subject receives placebo.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '13.9', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '13.0', 'spread': '2.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-15', 'studyFirstSubmitDate': '2006-12-15', 'resultsFirstSubmitDate': '2012-11-07', 'studyFirstSubmitQcDate': '2006-12-18', 'lastUpdatePostDateStruct': {'date': '2013-07-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-07', 'studyFirstPostDateStruct': {'date': '2006-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Percent Change From Baseline in Whole-body Insulin Sensitivity', 'timeFrame': '4 months', 'description': 'This describes the percent changes in insulin sensitivity. Insulin sensitivity was expressed as whole body insulin sensitivity index (WBISI) which is based on the values of insulin (microunits per milliliter) and glucose (milligrams per deciliter) obtained from the OGTT and the corresponding fasting values.The formula is: WBISI=10.000/square root of (fasting glucose x fasting insulin)x(mean glucose x mean insulin).'}, {'measure': 'Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat', 'timeFrame': '4 months', 'description': 'This describes the percent changes of the ratio between visceral and subcutaneous abdominal fat.'}, {'measure': 'Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT)', 'timeFrame': '4 months', 'description': 'This refers to the number of subjects that converted from IGT to NGT. NGT is defined as fasting glucose lower than 100 mg/dl and 2 hours glucose lower than 140 mg/dl. IGT is defined as 2 hours glucose higher than 140 mg/dl.'}, {'measure': 'Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF)', 'timeFrame': '4 months', 'description': 'It refers to the percent changes of hepatic fat content.'}], 'secondaryOutcomes': [{'measure': 'Mean Percent Change From Baseline in Adiponectin', 'timeFrame': '4 months', 'description': 'This refers to the changes of adiponectin levels.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Childhood and Adolescent Obesity', 'Metabolic phenotype', 'Impaired Glucose Tolerance', 'Type 2 Diabetes Mellitus', 'Insulin Sensitivity', 'Insulin Resistance', 'Abdominal fat partitioning', 'Impaired Glucose Tolerance (IGT)', 'Type 2 Diabetes Mellitus (T2DM)'], 'conditions': ['Obesity', 'Impaired Glucose Tolerance', 'Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether treatment of children and adolescents with Impaired Glucose Tolerance (IGT) with rosiglitazone will lead to improvements in insulin sensitivity and glucose tolerance.', 'detailedDescription': 'Impaired Glucose Tolerance (IGT) is a prelude to diabetes, which is increasing in prevalence in obese children and adolescents with marked obesity. This condition tends to progress to Type 2 Diabetes Mellitus (T2DM) at an alarmingly rapid tempo. The increased prevalence of childhood and adolescent obesity and greater risk of IGT, and progression to diabetes, in this population set the stage for a series of studies aimed at understanding the metabolic phenotype and natural history of pre-diabetes in obese youth. The investigators found that obese children and adolescents with IGT are characterized by marked insulin resistance related to altered lipid partitioning, favoring lipid deposition in the visceral and intramyocellular compartment. Furthermore, the investigators found an impairment of the acute insulin response in these youngsters. Follow-up revealed a rapid deterioration from IGT to frank diabetes. Based on these studies, there is a strong rationale for changing the balance between visceral and subcutaneous fat and muscle lipid content in a more favorable pattern in order to improve insulin sensitivity.\n\nThe primary objective of this study is to determine, in a group of ethnically diverse children and adolescents with IGT, whether treatment with rosiglitazone leads to improvements in insulin sensitivity and glucose tolerance. Secondary objectives are to determine whether rosiglitazone is safe and well tolerated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good general health\n* Aged 10 to 18 yrs (females: Tanner stage II-V;and males:testes size\\>6ml)\n* IGT based on 2-hr plasma glucose\\>140mg/dl and \\<200mg/dl during an OGTT.\n\nExclusion Criteria:\n\n* Baseline creatinine\\>1.0mg\n* AST and ALT\\>2.5 ULN\n* Anemia (Hct\\<30)\n* Pregnancy (females must have a negative urine pregnancy test during the study)\n* Cardiac or pulmonary or other significant chronic illness\n* Plans to increase the frequency or intensity of a regular exercise program\n* Psychiatric disorder or substance abuse of anorexic agents.'}, 'identificationModule': {'nctId': 'NCT00413335', 'briefTitle': 'Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth', 'orgStudyIdInfo': {'id': '0508000532'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.', 'interventionNames': ['Drug: Rosiglitazone']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Rosiglitazone', 'type': 'DRUG', 'otherNames': ['Avandia'], 'description': '2mg to begin then 4mg, twice daily for 4 months', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subject receives placebo.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Sonia Caprio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale School of Medicine Department of Pediatric Endocrinology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sonia Caprio', 'investigatorAffiliation': 'Yale University'}}}}