Activity and Metformin Intervention in Obese Adolescents (REACH)

October 3, 2012 updated by: Cheryl, Lawson Health Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Children's Hospital, London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in BMI
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in physical activity
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Cheril Clarson, MD, Lawson Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

July 6, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (Estimate)

July 8, 2009

Study Record Updates

Last Update Posted (Estimate)

October 4, 2012

Last Update Submitted That Met QC Criteria

October 3, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-08-259
  • 15590 (Other Identifier: REB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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