MedTrace Logo

Contribution of Hyperinsulinemia vs. Hyperglycemia to Insulin Resistance in Type 1 Diabetes and Maturity Onset Diabetes of the Young, Type 2 (MODY2)

NCT02971202 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-08-01

Study results available
· View outcomes & findings →

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.

Conditions

  • Type 1 Diabetes Mellitus
  • Maturity-Onset Diabetes of the Young, Type 2
  • MODY2
  • Insulin Resistance

Interventions

DRUG

Hyperinsulinemic, euglycemic clamp

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.

DRUG

20% dextrose

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.

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Justin M Gregory, MD · Vanderbilt University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
51 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02971202 on ClinicalTrials.gov