Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-04-17 @ 11:10 PM
Study NCT ID:
NCT02971202
Status:
COMPLETED
Last Update Posted:
2019-08-01
First Post:
2016-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Contribution of Hyperinsulinemia vs. Hyperglycemia to Insulin Resistance in Type 1 Diabetes and Maturity Onset Diabetes of the Young, Type 2 (MODY2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'C564219', 'term': 'Maturity-Onset Diabetes of the Young, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015309', 'term': 'Glucose Clamp Technique'}, {'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'justin.m.gregory.1@vumc.org', 'phone': '615-875-9669', 'title': 'Justin M. Gregory MD MSCI', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 week', 'description': 'per protocol, hyperglycemia and hypoglycemia are not considered adverse events unless serious', 'eventGroups': [{'id': 'EG000', 'title': 'Hyperinsulinemic, Euglycemic Clamp: T1DM', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 milliunit (mU)/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Hyperinsulinemic, Euglycemic Clamp:MODY2', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 mU/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Hyperinsulinemic Euglycemic Clamp:Control', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 mU/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 3, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vasovagal Response', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea and vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IV site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling at biopsy site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness at biopsy site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Whole-body Glucose Utilization (Rd)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyperinsulinemic, Euglycemic Clamp: T1DM', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 milliunit (mU)/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.'}, {'id': 'OG001', 'title': 'Hyperinsulinemic, Euglycemic Clamp:MODY2', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 mU/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.'}, {'id': 'OG002', 'title': 'Hyperinsulinemic Euglycemic Clamp:Control', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 mU/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '10.9'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '13.0'}, {'value': '12.1', 'groupId': 'OG002', 'lowerLimit': '10.3', 'upperLimit': '14.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of clamp study (the study will last 8 hours)', 'description': 'The primary outcome is the degree to which Rd (determined using isotopic glucose tracer techniques) during maximal insulin stimulation differs between cohorts.', 'unitOfMeasure': 'mg/kg FFM/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hepatic Insulin Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyperinsulinemic, Euglycemic Clamp: T1DM', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 milliunit (mU)/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.'}, {'id': 'OG001', 'title': 'Hyperinsulinemic, Euglycemic Clamp:MODY2', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 mU/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.'}, {'id': 'OG002', 'title': 'Hyperinsulinemic Euglycemic Clamp:Control', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 mU/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '2.2'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '2.4'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 1/2 hours into clamp study', 'description': 'Glucose production (Ra) will be determined using stable isotopic tracer techniques. The extent to which Ra is suppressed at the end of 4 1/2 hours (when glucose Ra by liver has been submaximally suppressed) compared to basal (ΔRa) is directly proportional to hepatic insulin sensitivity.', 'unitOfMeasure': 'mg/kg FFM/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adipose Tissue Insulin Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyperinsulinemic, Euglycemic Clamp: T1DM', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 milliunit (mU)/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.'}, {'id': 'OG001', 'title': 'Hyperinsulinemic, Euglycemic Clamp:MODY2', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 mU/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.'}, {'id': 'OG002', 'title': 'Hyperinsulinemic Euglycemic Clamp:Control', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 mU/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '122.4', 'groupId': 'OG000', 'lowerLimit': '-54.36', 'upperLimit': '299.1'}, {'value': '382.3', 'groupId': 'OG001', 'lowerLimit': '244.4', 'upperLimit': '520.3'}, {'value': '392.7', 'groupId': 'OG002', 'lowerLimit': '274.4', 'upperLimit': '511.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 1/2 hours into clamp study', 'description': "Insulin sensitivity at fat is directly proportional to insulin's ability to suppress lipolysis. Thus, we will determine the extent to which submaximal insulin stimulation (4 1/2 hours into the study) suppresses glycerol and non-esterified free fatty acids (NEFAs) compared to baseline. The extent to which these two metabolites are suppressed is directly proportional to insulin sensitivity in adipose tissue. Here the suppression of NEFA is taken as the secondary outcome parameter.", 'unitOfMeasure': 'μmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hyperinsulinemic, Euglycemic Clamp: T1DM', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 milliunit (mU)/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.'}, {'id': 'FG001', 'title': 'Hyperinsulinemic, Euglycemic Clamp:MODY2', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 mU/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.'}, {'id': 'FG002', 'title': 'Hyperinsulinemic Euglycemic Clamp:Control', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 mU/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Started Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'screen fail after consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Hyperinsulinemic, Euglycemic Clamp: T1DM', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 milliunit (mU)/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.'}, {'id': 'BG001', 'title': 'Hyperinsulinemic, Euglycemic Clamp:MODY2', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 mU/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.'}, {'id': 'BG002', 'title': 'Hyperinsulinemic Euglycemic Clamp:Control', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 mU/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '33', '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': '1', 'groupId': 'BG002'}, {'value': '1', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-24', 'size': 656894, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-30T11:56', 'hasProtocol': True}, {'date': '2018-09-20', 'size': 410188, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-07-29T11:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2016-10-27', 'resultsFirstSubmitDate': '2019-05-30', 'studyFirstSubmitQcDate': '2016-11-18', 'lastUpdatePostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-29', 'studyFirstPostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole-body Glucose Utilization (Rd)', 'timeFrame': 'End of clamp study (the study will last 8 hours)', 'description': 'The primary outcome is the degree to which Rd (determined using isotopic glucose tracer techniques) during maximal insulin stimulation differs between cohorts.'}], 'secondaryOutcomes': [{'measure': 'Hepatic Insulin Sensitivity', 'timeFrame': '4 1/2 hours into clamp study', 'description': 'Glucose production (Ra) will be determined using stable isotopic tracer techniques. The extent to which Ra is suppressed at the end of 4 1/2 hours (when glucose Ra by liver has been submaximally suppressed) compared to basal (ΔRa) is directly proportional to hepatic insulin sensitivity.'}, {'measure': 'Adipose Tissue Insulin Sensitivity', 'timeFrame': '4 1/2 hours into clamp study', 'description': "Insulin sensitivity at fat is directly proportional to insulin's ability to suppress lipolysis. Thus, we will determine the extent to which submaximal insulin stimulation (4 1/2 hours into the study) suppresses glycerol and non-esterified free fatty acids (NEFAs) compared to baseline. The extent to which these two metabolites are suppressed is directly proportional to insulin sensitivity in adipose tissue. Here the suppression of NEFA is taken as the secondary outcome parameter."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['o-glcnacylation', 'hexosamine'], 'conditions': ['Type 1 Diabetes Mellitus', 'Maturity-Onset Diabetes of the Young, Type 2', 'MODY2', 'Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '31092478', 'type': 'DERIVED', 'citation': 'Gregory JM, Smith TJ, Slaughter JC, Mason HR, Hughey CC, Smith MS, Kandasamy B, Greeley SAW, Philipson LH, Naylor RN, Letourneau LR, Abumrad NN, Cherrington AD, Moore DJ. Iatrogenic Hyperinsulinemia, Not Hyperglycemia, Drives Insulin Resistance in Type 1 Diabetes as Revealed by Comparison With GCK-MODY (MODY2). Diabetes. 2019 Aug;68(8):1565-1576. doi: 10.2337/db19-0324. Epub 2019 May 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the key factors influencing insulin sensitivity in type 1 diabetes (T1DM) and maturity onset diabetes of the young, type 2 (MODY2).\n\nOur study tests the hypothesis that decreased insulin sensitivity is primarily driven by chronically elevated insulin levels in the blood rather than chronic elevations in blood sugar.', 'detailedDescription': 'This research will determine whether insulin resistance (IR) in T1DM is predominantly an effect of chronic hyperglycemia, as is commonly accepted, or a consequence of iatrogenic hyperinsulinemia in the peripheral circulation, as alternatively hypothesized. IR is a consistent but under-recognized finding in T1DM. Despite its independent contribution to micro- and macrovascular disease, its underlying cause has not been established nor have strategies to mitigate it been developed. This research will also characterize IR in maturity onset diabetes of the young, type 2 (MODY2), a population for whom IR has been inadequately studied to date.\n\nInsulin therapy in T1DM attempts to achieve euglycemia but does so in an "unphysiologic" way, by delivering insulin into the subcutaneous tissue as compared to physiologic delivery directly into the hepatic portal circulation. Although life-saving, peripheral insulin delivery in T1DM results in a loss of the normal insulin distribution; the physiologic state maintains insulin at 3-fold higher concentrations in the portal circulation compared with the peripheral circulation. IR in T1DM could therefore occur in response to peripheral hyperinsulinemia, a mechanism that would protect against hypoglycemia and ensure adequate glucose delivery to the central nervous system.\n\nMODY2 is a condition that results a mutation in the gene encoding glucokinase (GCK), which in turn causes a defect in β-cell sensitivity to glucose due to reduced glucose phosphorylation. This effectively raises the "set point" for insulin secretion in response to increased glycemia. Because MODY2 patients retain pancreatic insulin secretion, they usually require no insulin therapy and have a normal insulin distribution between the portal and peripheral circulations.\n\nWe therefore hypothesize that IR in T1DM 1) is a homeostatic response to increased peripheral insulin concentrations resulting from peripheral insulin delivery and not significantly attributable to hyperglycemia and 2) results primarily from peripheral tissue IR (especially muscle) and not primarily from hepatic IR. Further, we anticipate that patients with MODY2, a population that has hyperglycemia without hyperinsulinemia, will have insulin sensitivity similar to that of otherwise healthy, nondiabetic individuals.\n\nTo test this hypothesis, the hyperinsulinemic, euglycemic clamp will be used to assess IR in a cross-sectional study of 3 groups of subjects:\n\n1. non-diabetic control subjects,\n2. patients with well controlled T1DM, and\n3. patients with MODY2\n\nKey metabolic differences between these 3 groups will enable us to parse out the relative contributions of peripheral hyperinsulinemia vs. hyperglycemia to IR in T1DM and MODY2. Further, the proposed research will provide information on whether novel therapeutic strategies to restore the normal portal to peripheral insulin distribution can normalize insulin sensitivity (e.g. hepatopreferential insulin analogs, intraperitoneal insulin delivery).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '51 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria for all subjects:\n\n\\- BMI 19-28 kg/m\\^2\n\nAdditional inclusion criteria for T1DM subjects:\n\n* Age 13-51\n* T1DM duration 1-20 years\n* HbA1c 5.9-8.0%\n\nAdditional inclusion criteria for MODY2 subjects:\n\n* age 13-51\n* positive GCK genetic sequencing\n* HbA1c 5.9-8.0%\n\nAdditional inclusion criteria for control subjects:\n\n* age 18-5.1\n* HbA1c \\< 5.5%\n\nExclusion Criteria:\n\nExclusion criteria for all subjects:\n\n* severe hypoglycemia (\\>= 1 episode in the past 3 months or diagnosis of hypoglycemia unawareness)\n* diabetes comorbidities (\\>= 1 trip to emergency department for poor glucose control in the past 6 months, New York Heart Association Class II-IV cardiac functional status, systolic blood pressure \\> 140 and diastolic blood pressure \\> 100 mmHg, fasting triglycerides \\> 400 mg/dL, liver transaminases \\> 2 times the upper limit of normal, renal transplantation or serum creatinine \\> 1.5 mg/dL)\n* confounding medications (any systemic glucocorticoid, any antipsychotic, atenolol, metoprolol, propranolol, niacin, any thiazide diuretic, any oral contraceptive pill with \\> 35 mcg ethinyl estradiol, growth hormone, any immunosuppressant, any anti-hypertensive, any-antilipidemic)\n* pregnancy\n* Tanner stage \\< 5\n\nAdditional exclusion criteria for T1DM subjects\n\n* any diabetes medication except insulin\n* fasting c-peptide \\> 0.7 ng/mL'}, 'identificationModule': {'nctId': 'NCT02971202', 'briefTitle': 'Contribution of Hyperinsulinemia vs. Hyperglycemia to Insulin Resistance in Type 1 Diabetes and Maturity Onset Diabetes of the Young, Type 2 (MODY2)', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'A Novel Cross-sectional Analysis of Insulin Sensitivity Among Adolescents and Young Adults With Type 1 Diabetes, MODY2, and Normal Controls: the Contribution of Hyperinsulinemia vs. Hyperglycemia to Insulin Resistance', 'orgStudyIdInfo': {'id': '161504'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Hyperinsulinemic, euglycemic clamp: T1DM', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 milliunit (mU)/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.', 'interventionNames': ['Drug: Hyperinsulinemic, euglycemic clamp', 'Drug: 20% dextrose']}, {'type': 'OTHER', 'label': 'Hyperinsulinemic, euglycemic clamp:MODY2', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 mU/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.', 'interventionNames': ['Drug: Hyperinsulinemic, euglycemic clamp', 'Drug: 20% dextrose']}, {'type': 'OTHER', 'label': 'Hyperinsulinemic euglycemic clamp:Control', 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 mU/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.\n\nA variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.', 'interventionNames': ['Drug: Hyperinsulinemic, euglycemic clamp', 'Drug: 20% dextrose']}], 'interventions': [{'name': 'Hyperinsulinemic, euglycemic clamp', 'type': 'DRUG', 'otherNames': ['glucose clamp', 'pancreatic clamp'], 'description': 'Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:\n\n* insulin (12 mU/m\\^2/min \\[3x basal\\] for 150 minutes, then 40 mU/m\\^2/min \\[10x basal\\] for 180 minutes)\n* glucagon (0.65 ng/kg/min \\[1x basal\\] for 330 minutes)\n* somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.', 'armGroupLabels': ['Hyperinsulinemic euglycemic clamp:Control', 'Hyperinsulinemic, euglycemic clamp: T1DM', 'Hyperinsulinemic, euglycemic clamp:MODY2']}, {'name': '20% dextrose', 'type': 'DRUG', 'description': 'A variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.', 'armGroupLabels': ['Hyperinsulinemic euglycemic clamp:Control', 'Hyperinsulinemic, euglycemic clamp: T1DM', 'Hyperinsulinemic, euglycemic clamp:MODY2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Justin M Gregory, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'The datasets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request. No applicable resources were generated or analyzed during the current study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Justin Gregory', 'investigatorAffiliation': 'Vanderbilt University'}}}}