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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Collaborator: National Institutes of Health (NIH)
• Treatments: Insulin; Metformin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)