Activity and Metformin Intervention in Obese Adolescents

Phase 4

Completed

• Conditions: Obesity; Type 2 Diabetes
• Interventions: Drug: Metformin and standard exercise; Behavioral: Placebo Standard exercise; Drug: Metformin Intensive exercise; Behavioral: Intensive exercise

• Registration Number: NCT00934570
• Lead Sponsor: Lawson Health Research Institute

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-07-06
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-08
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-03
• Last Update Posted: 2012-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin, Standard exercise	Metformin and standard exercise	Lifestyle intervention with metformin and standard exercise program.
Placebo, Standard exercise	Placebo Standard exercise	Lifestyle intervention with placebo and standard exercise program
Metformin, Intensive exercise	Metformin Intensive exercise	Lifestyle intervention with metformin and intensive exercise
Placebo, Intensive exercise	Intensive exercise	Lifestyle intervention with placebo and intensive exercise program.

Primary Outcome Measures

Name	Time	Method
Reduction in BMI	2 years

Secondary Outcome Measures

Name	Time	Method
Improvement in physical activity	2 years

Trial Locations

Locations (1)

Children's Hospital, London Health Sciences Centre; 🇨🇦 London, Ontario, Canada