Activity and Metformin Intervention in Obese Adolescents

This study will assess the sustainability of a two-year intervention and the degree of improvement in body mass index (BMI) and reduction in risk factors for type 2 diabetes and diabetes related cardiovascular disease, as well as evaluating the additive effect of metformin (as GlumetzaTM 500 mg Extended Release Tablets) and comparing an initial intensive exercise program with a standard exercise program. The study will recruit obese youth who are at risk for type 2 diabetes and cardiovascular disease.

Inclusion criteria

• Obese adolescents defined as BMI greater than the 95th percentile for age and gender
• Metformin naive subjects

Exclusion criteria

• Elevated fasting plasma glucose ≥ 6.0 mmol/L
• 2 hour plasma glucose ≥ 11.1 mmol/L after a standard glucose load
• A1C > 6.0%
• Medication other than "over the counter" drugs, oral contraceptive pill or thyroid hormone replacement
• Smoking
• Pregnancy
• Renal insufficiency (serum creatinine > the upper limit of normal)
• Hepatic dysfunction (> 1.5 times the upper limit of normal for AST and ALT)
• Latex Allergy
• Hypersensitivity to metformin or its ingredients
• Breast feeding
• Subjects with a history of lactic acidosis
• Abnormal creatinine clearance
• HIV, HBV, and HCV infections
• Drug and alcohol abuse
• Severe mental disorders
• Subjects who are planning radiologic exams involving in i.v. injection of iodinated contract materials
• Participation in another clinical trial
• Significant history or presence of cardiovascular, pulmonary, gastrointestinal, immunologic, endocrine, neurologic disorders
• Malignant diseases
• Previous exposure to any pharmaceutical antidiabetic agent