Activity and Metformin Intervention in Obese Adolescents

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the sustainability of a two-year intervention aimed at improving body mass index (BMI) and metabolic and vascular health in obese youth. The study will compare lifestyle changes with diet and exercise alone with changes in lifestyle in combination with metformin medication. An initial intensive exercise program will also be compared with a standard exercise program.

Hypothesis: Metformin therapy in combination with intensive lifestyle intervention in obese children and adolescents will be associated with reduced rate of weight gain, improved BMI, body composition, physical activity, physical fitness, insulin sensitivity, blood lipid profiles, adipocytokines and vascular function.

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

Details

• Lead Sponsor: Lawson Health Research Institute
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Metformin

Criteria

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