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NCT00015626 Clinical Trial

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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00015626
Other study ID # NCRR-M01RR06020-0057
Secondary ID
Status Completed
Phase Phase 2
First received April 24, 2001
Last updated June 23, 2005

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 5 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Metformin

Procedure:
• skin biopsy

Behavioral:
• diet and exercise

Drug:
• pioglitazone

• rosiglitazone

Locations
Country Name City State
United States Cornell University New York New York

Sponsors (1)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

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