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

National Center for Research Resources (NCRR)

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus; Insulin Resistance

Treatments: Procedure: skin biopsy; Behavioral: diet and exercise; Drug: pioglitazone; Drug: rosiglitazone; Drug: Metformin

Study type: Interventional

Funder types: NIH

Identifiers

NCT00015626

NCRR-M01RR06020-0057

Details and patient eligibility

About

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.

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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