Status:
COMPLETED
Activity and Metformin Intervention in Obese Adolescents
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Obesity
Type 2 Diabetes
Eligibility:
All Genders
10-16 years
Phase:
PHASE4
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 l...
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 cardi...
Eligibility Criteria
Inclusion
- Obese adolescents defined as BMI greater than the 95th percentile for age and gender
- Metformin naive subjects
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00934570
Start Date
April 1 2009
End Date
May 1 2012
Last Update
October 4 2012
Active Locations (1)
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1
Children's Hospital, London Health Sciences Centre
London, Ontario, Canada, N6A 5W9