Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    9669786 [PUBMED-IDS]

Insulin Clamp Ancillary Study for Assessment of Insulin Resistance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02045290
Recruitment Status : Completed
First Posted : January 24, 2014
Last Update Posted : March 14, 2017
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
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%).

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Metformin Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (T1D)--Insulin Clamp Ancillary Study for Assessment of Insulin Resistance
Study Start Date : January 2014
Actual Primary Completion Date : February 15, 2016
Actual Study Completion Date : February 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045290


Locations
Layout table for location information
United States, Florida
Jaeb Center for Health Research
Tampa, Florida, United States, 33647
Sponsors and Collaborators
Jaeb Center for Health Research
Juvenile Diabetes Research Foundation
Investigators
Layout table for investigator information
Principal Investigator: Kellee M Miller, MPH Jaeb Center for Health Research
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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT02045290     History of Changes
Other Study ID Numbers: T1DX Insulin Clamp Ancillary
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 1
Insulin Resistance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hyperinsulinism
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs