Activity and Metformin Intervention in Obese Adolescents (REACH)

Lawson Health Research Institute

Status and phase: Completed; Phase 4

Conditions: Obesity; Type 2 Diabetes

Treatments: Behavioral: Intensive exercise; Drug: Metformin Intensive exercise; Behavioral: Placebo Standard exercise; Drug: Metformin and standard exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT00934570

R-08-259

15590 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 10 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups, including a placebo group

Metformin, Standard exercise

Active Comparator group

Description:

Lifestyle intervention with metformin and standard exercise program.

Treatment:

Drug: Metformin and standard exercise

Placebo, Standard exercise

Placebo Comparator group

Description:

Lifestyle intervention with placebo and standard exercise program

Treatment:

Behavioral: Placebo Standard exercise

Metformin, Intensive exercise

Active Comparator group

Description:

Lifestyle intervention with metformin and intensive exercise

Treatment:

Drug: Metformin Intensive exercise

Placebo, Intensive exercise

Placebo Comparator group

Description:

Lifestyle intervention with placebo and intensive exercise program.

Treatment:

Behavioral: Intensive exercise