Metabolic Effect of Metformin in Obese Insulin Resistant Adolescents With Normal Glucose Tolerance

Completed · Phase 4 · Has a placebo group

Conditions studied: Pediatric Obesity, Insulin Resistance, Hyperinsulinemia

In brief

The primary objective of this randomized, parallel group, double-blind, placebo-controlled study is to determine whether treatment with metformin enhances insulin sensitivity in a group of ethnically diverse obese insulin-resistant adolescents with normal glucose tolerance.

Key facts

Study ID

NCT00667498

Run by

Yale University

People needed

28

Starts

2004-03-01

Expected to finish

2007-12-01

Last updated by the study team

2009-02-18

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Attending weight management clinic at Yale New Haven Hospital
• Good general health, taking no other medication on a chronic basis
• Age 13 to 17 yrs in puberty (girls: breast Tanner stage II to IV, and boys: testes size > 6 ml)
• The presence of insulin resistance, defined by fasting insulin levels greater than 30 µU/ml, and HOMA insulin resistance index > 6
• Normal glucose tolerance based on a 2-hr plasma glucose (<140 mg/dl) after the OGTT.
• All female subjects must have a negative urine pregnancy test during the study visits and must use an effective method of contraception if they are sexually active. Without their parent(s) present, all potential female subjects will be asked about their sexual activity and the specific form of contraception they are using.

You may not qualify if…

• Baseline creatinine > 1.0 mg/dl
• Hepatic disease with elevated liver function test (ALT or AST) ≥ 2 X the upper limits of normal
• Pregnancy
• Presence of other endocrinopathies; except treated hypothyroidism on stable replacement doses of thyroid hormone
• Presence of cardiac, pulmonary or other significant chronic illness
• Adolescents with psychiatric disorder, claustrophobia or with substance abuse
• Recent use (within six months) of anorexic agents
• Presence of anemia (hematocrit < 35)
• Mixed ethnic background (defined as two parents of different ethnicity)
• Adolescents with metal implants (i.e. cardiac pace maker, metal prostheses, bullet remnants)

Where it is running

• Yale Center for Clinical Investigation (YCCI) — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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