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Insulin Clamp Ancillary Study for Assessment of Insulin Resistance

NCT02045290 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2017-03-14

No results posted yet for this study

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%).

Conditions

Interventions

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.

DRUG

Placebo

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Kellee M Miller, MPH · Jaeb Center for Health Research

  • Ingrid Libman, MD, PhD · Childrens Hospital of University of Pittsburgh Medical Center

  • Kristen Nadeau, MD · University of Colorado Denver/Childrens Hospital Colorado

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-02-15
Completion
2016-02-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT02045290 on ClinicalTrials.gov