Activity and Metformin Intervention in Obese Adolescents

Obesity Clinical Trial

— REACH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934570
• Other study ID #: R-08-259
• Secondary ID: 15590
• Status: Completed
• Phase: Phase 4
• First received: July 6, 2009
• Last updated: October 3, 2012
• Start date: April 2009
• Est. completion date: May 2012

Study information

• Verified date: October 2012
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 16 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Drug:
• Metformin and standard exercise
Metformin 1500 mg daily for 2 years
• Metformin Intensive exercise
Metformin 1500 mg daily for 2 years

Behavioral:
• Placebo Standard exercise
Standard exercise
• Intensive exercise
Placebo Intensive exercise

Locations

Country	Name	City	State
Canada	Children's Hospital, London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in BMI		2 years	No
Secondary	Improvement in physical activity		2 years	No

External Links

•   Click here for more information about this study: Metformin and Activity Intervention in Obese Adolescents