Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-03-08 @ 5:06 AM
Study NCT ID:
NCT03582956
Status:
TERMINATED
Last Update Posted:
2024-04-03
First Post:
2018-06-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Adiposity on Hepatic and Peripheral Insulin Resistance in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michelle.vanname@yale.edu', 'phone': '2037855831', 'title': 'Michelle Van Name', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 hours', 'description': 'This is not a longitudinal study, and there was no intervention', 'eventGroups': [{'id': 'EG000', 'title': 'Adolescent Overweight', 'description': 'The study aims to enroll 36 adolescents with T1D and overweight/obesity, 36 lean adolescents with T1D, and 36 young adults with T1D that will receive a euglycemic hyperinsulinemic clamp with tracer enhancement.\n\nEuglycemic hyperinsulinemic clamp with tracer enhancement: To characterize the impact of adiposity on metabolism during puberty, adolescents will undergo the euglycemic hyperinsulinemic clamp study with tracer enhancement.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Adolescent Typical', 'description': 'The study aims to enroll 36 adolescents with T1D and overweight/obesity, 36 lean adolescents with T1D, and 36 young adults with T1D a euglycemic hyperinsulinemic clamp with tracer enhancement.\n\nEuglycemic hyperinsulinemic clamp with tracer enhancement: To characterize the impact of adiposity on metabolism during puberty, adolescents will undergo the euglycemic hyperinsulinemic clamp study with tracer enhancement.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Young Adult', 'description': 'Young adults with T1D a euglycemic hyperinsulinemic clamp with tracer enhancement.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Glucose Metabolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescent Overweight', 'description': 'Adolescents with T1D and overweight/obesity.\n\nEuglycemic hyperinsulinemic clamp with tracer enhancement: To characterize the impact of adiposity on metabolism during puberty, adolescents will undergo the euglycemic hyperinsulinemic clamp study with tracer enhancement.'}, {'id': 'OG001', 'title': 'Adolescent Typical', 'description': 'Lean adolescents with T1D.\n\nEuglycemic hyperinsulinemic clamp with tracer enhancement: To characterize the impact of adiposity on metabolism during puberty, adolescents will undergo the euglycemic hyperinsulinemic clamp study with tracer enhancement.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.74', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '1.56', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.525', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '120 minutes', 'description': 'Insulin function will be measured using a euglycemic hyperinsulinemic clamp procedure. A clamp measures insulin sensitivity. During the low does insulin phase, this reflects hepatic glucose metabolism, which is reported here. A higher glucose infusion rate number indicates more sensitivity to insulin; a lower number means more resistance to insulin.', 'unitOfMeasure': 'mg/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only adolescents were analyzed due to the availability of data in the aftermath of the COVID shutdown- data were not collected on the young adult group.'}, {'type': 'PRIMARY', 'title': 'Rate of Lipid Metabolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescent Overweight', 'description': 'Adolescents with T1D and overweight/obesity.\n\nEuglycemic hyperinsulinemic clamp with tracer enhancement: To characterize the impact of adiposity on metabolism during puberty, adolescents will undergo the euglycemic hyperinsulinemic clamp study with tracer enhancement.'}, {'id': 'OG001', 'title': 'Adolescent Typical', 'description': 'Lean adolescents with T1D.\n\nEuglycemic hyperinsulinemic clamp with tracer enhancement: To characterize the impact of adiposity on metabolism during puberty, adolescents will undergo the euglycemic hyperinsulinemic clamp study with tracer enhancement.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.099', 'spread': '0.077', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.099', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.607', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '120 minutes', 'description': 'Insulin function will be measured using a euglycemic hyperinsulinemic clamp procedure. A clamp measures insulin sensitivity. During the low dose insulin phase, glycerol turnover (rate of appearance) can reflect adipose specific insulin sensitivity, which is reported here. Insulin should suppress glycerol turnover. A higher number reflects more resistance to insulin; a lower number means more sensitivity to insulin.', 'unitOfMeasure': 'mg/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only adolescents were analyzed due to the availability of data in the aftermath of the COVID shutdown- data were not collected on the young adult group.'}, {'type': 'PRIMARY', 'title': 'Hepatic Sensitivity to Low Dose Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescent Overweight', 'description': 'Adolescents with T1D and overweight/obesity.\n\nEuglycemic hyperinsulinemic clamp with tracer enhancement: To characterize the impact of adiposity on metabolism during puberty, adolescents will undergo the euglycemic hyperinsulinemic clamp study with tracer enhancement.'}, {'id': 'OG001', 'title': 'Adolescent Typical', 'description': 'Lean adolescents with T1D.\n\nEuglycemic hyperinsulinemic clamp with tracer enhancement: To characterize the impact of adiposity on metabolism during puberty, adolescents will undergo the euglycemic hyperinsulinemic clamp study with tracer enhancement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.9', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '-35.8', 'spread': '15.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.466', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '120 minutes', 'description': 'Insulin function will be measured using a euglycemic hyperinsulinemic clamp procedure. A clamp measures insulin sensitivity. Insulin should suppress glucose production. Change of the glucose rate of appearance (which is reported here, and the glucose rate of appearance is measured here utilizing isotopic enrichment) during the low dose insulin phase reflects hepatic sensitivity to insulin. A greater degree of decline reflects more sensitivity to insulin; a smaller number means more resistance to insulin.\n\nThis is calculated as the low dose insulin phase glucose rate of appearance minus the baseline phase glucose rate of appearance, divided by the basal phase glucose rate of appearance and multiplied x 100.', 'unitOfMeasure': 'percentage of suppression of Ra glucose', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only adolescents were analyzed due to the availability of data in the aftermath of the COVID shutdown- data were not collected on the young adult group.'}, {'type': 'PRIMARY', 'title': 'Peripheral Sensitivity to High Dose Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescent Overweight', 'description': 'Adolescents with T1D and overweight/obesity.\n\nEuglycemic hyperinsulinemic clamp with tracer enhancement: To characterize the impact of adiposity on metabolism during puberty, adolescents will undergo the euglycemic hyperinsulinemic clamp study with tracer enhancement.'}, {'id': 'OG001', 'title': 'Adolescent Typical', 'description': 'Lean adolescents with T1D.\n\nEuglycemic hyperinsulinemic clamp with tracer enhancement: To characterize the impact of adiposity on metabolism during puberty, adolescents will undergo the euglycemic hyperinsulinemic clamp study with tracer enhancement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-75.99', 'spread': '58.8', 'groupId': 'OG000'}, {'value': '-96.48', 'spread': '32.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.414', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '240 minutes', 'description': 'Insulin function will be measured using a euglycemic hyperinsulinemic clamp procedure. A clamp measures insulin sensitivity. Insulin should suppress glucose production. Change of the glucose rate of appearance (which is reported here, and the glucose rate of appearance is measured here utilizing isotopic enrichment) during the high dose phase reflects peripheral sensitivity to insulin. A greater degree of decline reflects more sensitivity to insulin; a smaller number means more resistance to insulin.\n\nThis is calculated as the high dose insulin phase glucose rate of appearance minus the baseline phase glucose rate of appearance, divided by the basal phase glucose rate of appearance and multiplied x 100.', 'unitOfMeasure': 'percentage of suppression of Ra glucose', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only adolescents were analyzed due to the availability of data in the aftermath of the COVID shutdown- data were not collected on the young adult group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adolescent Overweight', 'description': 'Adolescents with T1D and body mass index ≥85% will undergo a euglycemic hyperinsulinemic clamp with tracer enhancement.\n\nEuglycemic hyperinsulinemic clamp with tracer enhancement: To characterize the impact of adiposity on metabolism during puberty, adolescents will undergo the euglycemic hyperinsulinemic clamp study with tracer enhancement.'}, {'id': 'FG001', 'title': 'Adolescent Typical', 'description': 'Adolescents with T1D and body mass index \\<75% will undergo a euglycemic hyperinsulinemic clamp with tracer enhancement.\n\nEuglycemic hyperinsulinemic clamp with tracer enhancement: To characterize the impact of adiposity on metabolism during puberty, adolescents will undergo the euglycemic hyperinsulinemic clamp study with tracer enhancement.'}, {'id': 'FG002', 'title': 'Young Adult', 'description': 'Young Adults with T1D and body mass index 18.5 to \\<25 kg/m2 will undergo a euglycemic hyperinsulinemic clamp with tracer enhancement.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'One participant enrolled but did not have any baseline or study data obtained due to scheduling conflicts.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Adolescent Typical Weight', 'description': 'Adolescents with T1D and body mass index \\<75% will undergo a euglycemic hyperinsulinemic clamp with tracer enhancement.\n\nEuglycemic hyperinsulinemic clamp with tracer enhancement: To characterize the impact of adiposity on metabolism during puberty, adolescents will undergo the euglycemic hyperinsulinemic clamp study with tracer enhancement.'}, {'id': 'BG001', 'title': 'Adolescent Overweight/Obese', 'description': 'Adolescents with T1D and body mass index ≥85% will undergo a euglycemic hyperinsulinemic clamp with tracer enhancement.\n\nEuglycemic hyperinsulinemic clamp with tracer enhancement: To characterize the impact of adiposity on metabolism during puberty, adolescents will undergo the euglycemic hyperinsulinemic clamp study with tracer enhancement.'}, {'id': 'BG002', 'title': 'Young Adult', 'description': 'Young Adults with T1D and body mass index 18.5 to \\<25 kg/m2 will undergo a euglycemic hyperinsulinemic clamp with tracer enhancement.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'spread': '1.11', 'groupId': 'BG000'}, {'value': '14.5', 'spread': '1.19', 'groupId': 'BG001'}, {'value': '20.65', 'spread': '2.48', 'groupId': 'BG002'}, {'value': '15.57', 'spread': '2.03', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'percentage of glycated hemoglobin', 'classes': [{'categories': [{'measurements': [{'value': '7.32', 'spread': '0.60', 'groupId': 'BG000'}, {'value': '7.74', 'spread': '0.41', 'groupId': 'BG001'}, {'value': '6.35', 'spread': '0.49', 'groupId': 'BG002'}, {'value': '7.48', 'spread': '0.62', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline characteristics are provided for each group.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-14', 'size': 10362256, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-11T16:04', 'hasProtocol': True}, {'date': '2022-06-28', 'size': 249897, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-13T15:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'Covid', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'dispFirstSubmitDate': '2023-04-06', 'completionDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2018-06-15', 'resultsFirstSubmitDate': '2023-08-14', 'studyFirstSubmitQcDate': '2018-06-27', 'dispFirstPostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-05', 'studyFirstPostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Glucose Metabolism', 'timeFrame': '120 minutes', 'description': 'Insulin function will be measured using a euglycemic hyperinsulinemic clamp procedure. A clamp measures insulin sensitivity. During the low does insulin phase, this reflects hepatic glucose metabolism, which is reported here. A higher glucose infusion rate number indicates more sensitivity to insulin; a lower number means more resistance to insulin.'}, {'measure': 'Rate of Lipid Metabolism', 'timeFrame': '120 minutes', 'description': 'Insulin function will be measured using a euglycemic hyperinsulinemic clamp procedure. A clamp measures insulin sensitivity. During the low dose insulin phase, glycerol turnover (rate of appearance) can reflect adipose specific insulin sensitivity, which is reported here. Insulin should suppress glycerol turnover. A higher number reflects more resistance to insulin; a lower number means more sensitivity to insulin.'}, {'measure': 'Hepatic Sensitivity to Low Dose Insulin', 'timeFrame': '120 minutes', 'description': 'Insulin function will be measured using a euglycemic hyperinsulinemic clamp procedure. A clamp measures insulin sensitivity. Insulin should suppress glucose production. Change of the glucose rate of appearance (which is reported here, and the glucose rate of appearance is measured here utilizing isotopic enrichment) during the low dose insulin phase reflects hepatic sensitivity to insulin. A greater degree of decline reflects more sensitivity to insulin; a smaller number means more resistance to insulin.\n\nThis is calculated as the low dose insulin phase glucose rate of appearance minus the baseline phase glucose rate of appearance, divided by the basal phase glucose rate of appearance and multiplied x 100.'}, {'measure': 'Peripheral Sensitivity to High Dose Insulin', 'timeFrame': '240 minutes', 'description': 'Insulin function will be measured using a euglycemic hyperinsulinemic clamp procedure. A clamp measures insulin sensitivity. Insulin should suppress glucose production. Change of the glucose rate of appearance (which is reported here, and the glucose rate of appearance is measured here utilizing isotopic enrichment) during the high dose phase reflects peripheral sensitivity to insulin. A greater degree of decline reflects more sensitivity to insulin; a smaller number means more resistance to insulin.\n\nThis is calculated as the high dose insulin phase glucose rate of appearance minus the baseline phase glucose rate of appearance, divided by the basal phase glucose rate of appearance and multiplied x 100.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type1 Diabetes Mellitus', 'Adiposity']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the effects of adiposity on resistance to insulin's ability to suppress hepatic glucose production and to stimulate peripheral glucose metabolism in adolescents with type 1 diabetes. In addition, this study will also examine the role of fatty liver disease on the insulin resistance of obesity in adolescents with type 1 diabetes.", 'detailedDescription': "A major focus of this program of research will be directed at advancing the understanding of the metabolic consequences of obesity and puberty in adolescents with T1D. Thus, an innovative aspect of this research is that it will be the first to use these sophisticated metabolic techniques to examine the effects of obesity and hepatic steatosis on insulin sensitivity in pubertal adolescents with T1D; namely, the 2-step hyperinsulinemic euglycemic clamp with tracer enhancement, which will allow for definition of hepatic and peripheral insulin resistance, glycerol turnover, and glucose and fat oxidation. Further, a second novel aspect is that this will be the first study to utilize gold standard MRI methods to quantify and compare intrahepatic fat content in lean and obese adolescents with T1D. This will allow a global and more detailed understanding of the potential alterations of insulin's effects on key insulin sensitive tissues in youth that are impacted by both T1D and obesity. Furthermore, evaluation of biomarkers for insulin resistance and fatty liver disease in this population will be performed for the first time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Participants:\n\n 1. Clinical diagnosis of T1D\n 2. HbA1c ≤9%\n 3. Diabetes duration of at least 12 months\n\nAdolescents with T1D:\n\n1. Age 12-16 years\n2. BMI \\<75th for lean pediatric subjects, \\> 85th percentile for overweight/obese pediatric subjects;\n3. Tanner stage 2-5\n4. Parent able to provide written consent and participant able to provide assent\n5. Not meeting MRI safety criteria\n6. Claustrophobia that will prevent participation in the MRI\n\nLean, young adults with T1D:\n\n1. Age 18-24 years\n2. BMI 18.5-24.9 kg/m2\n3. Able to provide written consent.\n\nExclusion Criteria:\n\n1. Use of adjunctive diabetes medications\n2. Weight loss medications within the past six months\n3. Current psychiatric disorders, including eating disorders (DSM-V criteria)\n4. Known liver disease other than nonalcoholic hepatic steatosis\n5. Females who are pregnant or lactating\n6. Anemia or another medical condition that precludes participation in the study'}, 'identificationModule': {'nctId': 'NCT03582956', 'acronym': 'T1D', 'briefTitle': 'Effect of Adiposity on Hepatic and Peripheral Insulin Resistance in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Effect of Adiposity on Hepatic and Peripheral Insulin Resistance in Type 1 Diabetes', 'orgStudyIdInfo': {'id': '2000023149'}, 'secondaryIdInfos': [{'id': '1K23DK115894-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K23DK115894-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Adolescent Overweight', 'description': 'Adolescents with T1D and overweight/obesity', 'interventionNames': ['Procedure: Euglycemic hyperinsulinemic clamp with tracer enhancement']}, {'type': 'OTHER', 'label': 'Adolescent Typical', 'description': 'Lean adolescents with T1D', 'interventionNames': ['Procedure: Euglycemic hyperinsulinemic clamp with tracer enhancement']}, {'type': 'OTHER', 'label': 'Young Adult', 'description': 'Young adults with T1D with a euglycemic hyperinsulinemic clamp with tracer enhancement', 'interventionNames': ['Procedure: Euglycemic hyperinsulinemic clamp with tracer enhancement']}], 'interventions': [{'name': 'Euglycemic hyperinsulinemic clamp with tracer enhancement', 'type': 'PROCEDURE', 'description': 'To characterize the impact of adiposity on metabolism during puberty, adolescents will undergo the euglycemic hyperinsulinemic clamp study with tracer enhancement.', 'armGroupLabels': ['Adolescent Overweight', 'Adolescent Typical']}, {'name': 'Euglycemic hyperinsulinemic clamp with tracer enhancement', 'type': 'PROCEDURE', 'description': 'A comparison control group of 36 lean young adults with T1D will also be enrolled, since they will be unaffected by the adverse metabolic effects of puberty or obesity.', 'armGroupLabels': ['Young Adult']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Pediatric Diabetes Research Program', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Michelle Van Name, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}