REACH: Activity and Metformin Intervention in Obese Adolescents

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00934570

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Type 2 Diabetes	Drug: Metformin and standard exercise Drug: Metformin Intensive exercise Behavioral: Placebo Standard exercise Behavioral: Intensive exercise	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Reduction of Adolescent Risk Factors for Type 2 Diabetes and Cardiovascular Disease

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Metformin, Standard exercise Lifestyle intervention with metformin and standard exercise program.	Drug: Metformin and standard exercise Metformin 1500 mg daily for 2 years Other Names: GlumetzaTM 500 mg Extended Release
Placebo Comparator: Placebo, Standard exercise Lifestyle intervention with placebo and standard exercise program	Behavioral: Placebo Standard exercise Standard exercise
Active Comparator: Metformin, Intensive exercise Lifestyle intervention with metformin and intensive exercise	Drug: Metformin Intensive exercise Metformin 1500 mg daily for 2 years Other Names: GlumetzaTM 500 mg Extended Release
Placebo Comparator: Placebo, Intensive exercise Lifestyle intervention with placebo and intensive exercise program.	Behavioral: Intensive exercise Placebo Intensive exercise

Outcome Measures

Primary Outcome Measures

Reduction in BMI [2 years]

Secondary Outcome Measures

Improvement in physical activity [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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