Insulin Clamp Ancillary Study for Assessment of Insulin Resistance

March 10, 2017 updated by: Jaeb Center for Health Research

Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (T1D)--Insulin Clamp Ancillary Study for Assessment of Insulin Resistance

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%).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33647
        • Jaeb Center for Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin
Metformin 2000 mg per day
Drug: Metformin
The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in the morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
Placebo Comparator: Oral 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
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hepatic IR from baseline to 13 weeks
Time Frame: 0-13 weeks

Graded hyperinsulinemic euglycemic clamp with glucose and glycerol isotopes to assess metformin's impact on:

• Hepatic IR
0-13 weeks
Change in Adipose IR from baseline to 13 weeks
Time Frame: 0-13 weeks

Graded hyperinsulinemic euglycemic clamp with glucose and glycerol isotopes to assess metformin's impact on:

• Adipose IR
0-13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaeb Center for Health Research

Collaborators

Juvenile Diabetes Research Foundation

Investigators

  • Study Chair: Ingrid Libman, MD, PhD, Childrens Hospital of University of Pittsburgh Medical Center
  • Study Chair: Kristen Nadeau, MD, University of Colorado Denver/Childrens Hospital Colorado
  • Principal Investigator: Kellee M Miller, MPH, Jaeb Center for Health Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

February 15, 2016

Study Completion (Actual)

February 15, 2016

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 10, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T1DX Insulin Clamp Ancillary

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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