Activity and Metformin Intervention in Obese Adolescents
NCT ID: NCT00934570
Last Updated: 2012-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2009-04-30
2012-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Metformin, Standard exercise
Lifestyle intervention with metformin and standard exercise program.
Metformin and standard exercise
Metformin 1500 mg daily for 2 years
Placebo, Standard exercise
Lifestyle intervention with placebo and standard exercise program
Placebo Standard exercise
Standard exercise
Metformin, Intensive exercise
Lifestyle intervention with metformin and intensive exercise
Metformin Intensive exercise
Metformin 1500 mg daily for 2 years
Placebo, Intensive exercise
Lifestyle intervention with placebo and intensive exercise program.
Intensive exercise
Placebo Intensive exercise
Interventions
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Metformin and standard exercise
Metformin 1500 mg daily for 2 years
Metformin Intensive exercise
Metformin 1500 mg daily for 2 years
Placebo Standard exercise
Standard exercise
Intensive exercise
Placebo Intensive exercise
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metformin naive subjects
Exclusion Criteria
* 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
10 Years
16 Years
ALL
Yes
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Cheryl
Dr Cheril Clarson
Principal Investigators
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Cheril Clarson, MD
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Locations
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Children's Hospital, London Health Sciences Centre
London, Ontario, Canada
Countries
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References
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Clarson CL, Brown HK, De Jesus S, Jackman M, Mahmud FH, Prapavessis H, Robinson T, Shoemaker JK, Watson M, Dowd AJ, Hill DJ. Effects of a Comprehensive, Intensive Lifestyle Intervention Combined with Metformin Extended Release in Obese Adolescents. Int Sch Res Notices. 2014 Nov 10;2014:659410. doi: 10.1155/2014/659410. eCollection 2014.
Wilson AJ, Prapavessis H, Jung ME, Cramp AG, Vascotto J, Lenhardt L, Shoemaker JK, Watson M, Robinson T, Clarson CL. Lifestyle modification and metformin as long-term treatment options for obese adolescents: study protocol. BMC Public Health. 2009 Nov 30;9:434. doi: 10.1186/1471-2458-9-434.
Related Links
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Click here for more information about this study: Metformin and Activity Intervention in Obese Adolescents
Other Identifiers
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15590
Identifier Type: OTHER
Identifier Source: secondary_id
R-08-259
Identifier Type: -
Identifier Source: org_study_id