Activity and Metformin Intervention in Obese Adolescents (REACH)

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Cheryl, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00934570
First received: July 6, 2009
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Obesity
Type 2 Diabetes
Drug: Metformin and standard exercise
Drug: Metformin Intensive exercise
Behavioral: Placebo Standard exercise
Behavioral: Intensive exercise
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Reduction of Adolescent Risk Factors for Type 2 Diabetes and Cardiovascular Disease

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Reduction in BMI [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in physical activity [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: GlumetzaTM 500 mg Extended Release
Placebo Comparator: Placebo, Intensive exercise
Lifestyle intervention with placebo and intensive exercise program.
Behavioral: Intensive exercise
Placebo Intensive exercise

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.

  Eligibility

Ages Eligible for Study:   10 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934570

Locations
Canada, Ontario
Children's Hospital, London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Cheril Clarson, MD Lawson Health Research Institute
  More Information

Additional Information:
No publications provided by Lawson Health Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheryl, Dr Cheril Clarson, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00934570     History of Changes
Other Study ID Numbers: R-08-259, 15590
Study First Received: July 6, 2009
Last Updated: October 3, 2012
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
Obesity
Metformin
Physical activity
Cardiovascular health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Body Weight
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014