Insulin Clamp Ancillary Study for Assessment of Insulin Resistance

Overview[ - collapse ][ - ]

Purpose 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 6-month randomized trial comparing metformin versus placebo in 12 to <20 year olds with BMI >85th percentile ( total daily insulin dose >0.8 units/kg, and HbA1c 7.5%-9.9%).
ConditionType 1 Diabetes
InterventionDrug: Metformin
Drug: Placebo
PhasePhase 3
SponsorT1D Exchange Clinic Network Coordinating Center
Responsible PartyT1D Exchange Clinic Network Coordinating Center
ClinicalTrials.gov IdentifierNCT02045290
First ReceivedJanuary 15, 2014
Last UpdatedJanuary 22, 2014
Last verifiedJanuary 2014

Tracking Information[ + expand ][ + ]

First Received DateJanuary 15, 2014
Last Updated DateJanuary 22, 2014
Start DateJanuary 2014
Estimated Primary Completion DateApril 2015
Current Primary Outcome MeasuresChange in insulin resistance (IR) from baseline to 13 weeks [Time Frame: 0-13 weeks] [Designated as safety issue: No]Hyperinsulinemic euglycemic clamp to assess metformin's impact on muscle IR via glucose infusion rate (GIR).
Current Secondary Outcome Measures
  • Change in Hepatic IR from baseline to 13 weeks [Time Frame: 0-13 weeks] [Designated as safety issue: No]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 [Time Frame: 0-13 weeks] [Designated as safety issue: No]Graded hyperinsulinemic euglycemic clamp with glucose and glycerol isotopes to assess metformin's impact on:
    • Adipose IR

Descriptive Information[ + expand ][ + ]

Brief TitleInsulin Clamp Ancillary Study for Assessment of Insulin Resistance
Official TitleMetformin Therapy for Overweight Adolescents With Type 1 Diabetes (T1D)--Insulin Clamp Ancillary Study for Assessment of Insulin Resistance
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 6-month randomized trial comparing metformin versus placebo in 12 to <20
year olds with BMI >85th percentile ( total daily insulin dose >0.8 units/kg, and HbA1c
7.5%-9.9%).
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionType 1 Diabetes
InterventionDrug: 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
Study Arm (s)
  • 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
  • Experimental: Metformin
    Metformin 2000 mg per day

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment44
Estimated Completion DateApril 2015
Estimated Primary Completion DateJanuary 2015
Eligibility 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
GenderBoth
Ages12 Years
Accepts Healthy VolunteersNo
ContactsContact: Kellee M Miller, MPH
813-975-8690
t1dstats@jaeb.org
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT02045290
Other Study ID NumbersT1DX Insulin Clamp Ancillary
Has Data Monitoring CommitteeYes
Information Provided ByT1D Exchange Clinic Network Coordinating Center
Study SponsorT1D Exchange Clinic Network Coordinating Center
CollaboratorsJuvenile Diabetes Research Foundation
Investigators Principal Investigator: Kellee M Miller, MPH Jaeb Center for Health ResearchStudy Chair: Ingrid Libman, MD, PhD Childrens Hospital of University of Pittsburgh Medical CenterStudy Chair: Kristen Nadeau, MD University of Colorado Denver/Childrens Hospital Colorado
Verification DateJanuary 2014

Locations[ + expand ][ + ]

Jaeb Center for Health Research
Tampa, Florida, United States, 33647
Contact: Kellee M Miller, MPH | 813-975-8690 | t1dstats@jaeb.org
Principal Investigator: Kellee M Miller, MPH
Recruiting