Clincosm LogoSign in Get a demo

A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)

Sponsor
National Center for Research Resources (NCRR) (NIH)
Overall Status
Completed
CT.gov ID
NCT00015626
Collaborator
(none)
300
Enrollment
1
Location

Study Details

Study Description

Brief Summary

The goal of this study is to aggressively treat insulin resistance and its clinical manifestations when they first appear in childhood, and to prevent the subsequent progression towards impaired glucose tolerance and type-2 diabetes. In the process of this clinical trial, we will learn more about the early manifestations of insulin resistance, its treatment, and its relationship to obesity and type-2 diabetes through parallel in-vivo and in-vitro studies.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    1. Obese patients (wt > 95th percentile for age, for adults increased BMI > 27) greater than 5 years of age

    2. And/or presence of complications of insulin resistance such as acanthosis nigricans, dyslipidemia, elevated blood pressure, hyperandrogenism

    3. Siblings and parents of patients with insulin resistance. Siblings and parents will be included only in the case of documented insulin resistance in the index subject. Insulin resistance will be documented by OGTT and/or IVGTT.

    4. Family history of type II diabetes.

    Exclusion Criteria:

    1. Critically ill patients, patients will congestive heart failure, renal or liver insufficiency

    2. Inability to give consent.

    3. History of poor compliance with physician's recommendations

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cornell University New York New York United States 10021

    Sponsors and Collaborators

    • National Center for Research Resources (NCRR)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00015626
    Other Study ID Numbers:
    • NCRR-M01RR06020-0057
    First Posted:
    Apr 26, 2001
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Dec 1, 2003
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Insulin Resistance
    Metformin
    Pioglitazone
    Rosiglitazone

    Study Results

    No Results Posted as of Jun 24, 2005