Insulin Clamp Ancillary Study for Assessment of Insulin Resistance

Phase 3

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Metformin; Drug: Placebo

• Registration Number: NCT02045290
• Lead Sponsor: Jaeb Center for Health Research

Brief Summary

Insulin Clamp Ancillary study for Assessment of Insulin Resistance will be conducted as a sub-study to the main protocol, Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (NCT01881828). The purpose of this ancillary study is to assess if metformin will improve tissue-specific insulin resistance (IR) in type 1 diabetes using a hyperinsulinemic euglycemic clamp; a 3-month randomized trial comparing metformin versus placebo in 12 to \<20 year olds with BMI \>85th percentile ( total daily insulin dose \>0.7 units/kg, and HbA1c 7.0%-9.9%).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Primary Completion: 2016-02-15
• Study Completion: 2016-02-15
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-10
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

1. Meets eligibility criteria of the main study, Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (NCT01881828).

Exclusion Criteria

1. Low hemoglobin or hematocrit as defined by each local institution's rules for insulin clamps or if no institutional requirements a Hematocrit <30% or hemoglobin <10 gm/dL

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	Metformin 2000 mg per day
Oral Placebo	Placebo	A central pharmacy will compound a placebo to match the metformin tablets. The placebo product will contain the following components: * Micosolle™, silica based excipient * Silicified Micro Crystalline Cellulose, National Formulary * Safflower Oil, United States Pharmacopeia * K-30 Povidone Powder * Magnesium Stearate, National Formulary (Vegetable source) * Fumed Silica, National Formulary

Primary Outcome Measures

Name	Time	Method
Change in insulin resistance (IR) from baseline to 13 weeks	0-13 weeks	Hyperinsulinemic euglycemic clamp to assess metformin's impact on muscle IR via glucose infusion rate (GIR).

Secondary Outcome Measures

Name	Time	Method
Change in Hepatic IR from baseline to 13 weeks	0-13 weeks	Graded hyperinsulinemic euglycemic clamp with glucose and glycerol isotopes to assess metformin's impact on: • Hepatic IR
Change in Adipose IR from baseline to 13 weeks	0-13 weeks	Graded hyperinsulinemic euglycemic clamp with glucose and glycerol isotopes to assess metformin's impact on: • Adipose IR

Trial Locations

Locations (1)

Jaeb Center for Health Research; 🇺🇸 Tampa, Florida, United States