CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 33 enrolled
Drug / intervention
Hyperinsulinemic, euglycemic clamp +1 moredrug
Likely dose
Insulin infusion 12 mU/m²/min for 150 minutes, then 40 mU/m²/min for 180 minutes; 20% dextrose variable infusion to maintain euglycemia; 6,6-H2 glucose 0.033-0.22 µmol/kg/minAI-extracted
Key inclusion· 8
  • ✓BMI 19-28 kg/m²
  • ✓Age 13-51 for T1DM and MODY2 subjects; age 18-51 for control subjects
  • ✓T1DM duration 1-20 years (T1DM subjects only)
  • ✓HbA1c 5.9-8.0% for T1DM subjects
Key exclusion· 10
  • ✕Severe hypoglycemia (≥1 episode in past 3 months or diagnosis of hypoglycemia unawareness)
  • ✕≥1 emergency department visit for poor glucose control in past 6 months
  • ✕New York Heart Association Class II-IV cardiac functional status
  • ✕Systolic BP >140 mmHg or diastolic BP >100 mmHg

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02971202
NCT02971202Phase 1Completed
CompareCT.gov

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

Vanderbilt University·interventional·Posted Nov 22, 2016·Updated Aug 1, 2019

In Brief

A Phase 1 clinical trial evaluating Hyperinsulinemic, euglycemic clamp and 20% dextrose for Type 1 Diabetes Mellitus and 3 related conditions. Completed, enrolled 33 participants across 1 site.

Detailed Summary

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). Our 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus, Maturity-Onset Diabetes of the Young, Type 2, MODY2, Insulin Resistance
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 22, 2016
Enrollment StartDec 1, 2016
Primary CompletionFeb 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.6 years ago

Interventions

Hyperinsulinemic, euglycemic clampdrug

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: * insulin (12 mU/m\^2/min \[3x basal\] for 150 minutes, then 40 mU/m\^2/min \[10x basal\] for 180 minutes) * glucagon (0.65 ng/kg/min \[1x basal\] for 330 minutes) * 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.

20% dextrosedrug

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.