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Completed

NCT Number: NCT02045290

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%).

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jaeb Center for Health Research

Tampa, Florida, 33647, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

metformin

Drug

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

Drug

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Jaeb Center for Health Research

Other

Collaborators

  • Juvenile Diabetes Research Foundation

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 24, 2014
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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