Status:
COMPLETED
Metabolic Effect of Metformin in Obese Insulin Resistant Adolescents With Normal Glucose Tolerance
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Pediatric Obesity
Insulin Resistance
Eligibility:
All Genders
13-17 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
First Visit Patients who agree to participate in this research study, will have an initial screening where the subject will be asked about his/her health, a sample of blood will be drawn, the subject...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00667498
Start Date
March 1 2004
End Date
December 1 2007
Last Update
February 18 2009
Active Locations (1)
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1
Yale Center for Clinical Investigation (YCCI)
New Haven, Connecticut, United States, 06511