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Trial NCT00934570

Resource URI: http://static.linkedct.org/resource/trials/NCT00934570
linkedct:acronym REACH
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/53028>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/53029>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/58251>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/58255>
linkedct:brief_title Activity and Metformin Intervention in Obese Adolescents
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1060>
linkedct:condition <http://static.linkedct.org/resource/condition/13330>
linkedct:condition <http://static.linkedct.org/resource/condition/9106>
linkedct: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
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers Accepts Healthy Volunteers
linkedct:eligibility_maximum_age 16 Years
linkedct:eligibility_minimum_age 10 Years
linkedct:end_date April 2012
linkedct:enrollment 60 (xsd:int)
linkedct:firstreceived_date July 6, 2009
linkedct:has_dmc No
linkedct:id NCT00934570
linkedct:intervention <http://static.linkedct.org/resource/intervention/106810>
linkedct:intervention <http://static.linkedct.org/resource/intervention/90542>
linkedct:intervention <http://static.linkedct.org/resource/intervention/96182>
linkedct:intervention <http://static.linkedct.org/resource/intervention/96201>
rdfs:label Trial NCT00934570
linkedct:lastchanged_date September 2, 2009
linkedct:lead_sponsor_agency Lawson Health Research Institute
linkedct:location <http://static.linkedct.org/resource/location/265085>
linkedct:nct_id NCT00934570
linkedct:number_of_arms 4 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Reduction of Adolescent Risk Factors for Type 2 Diabetes and Cardiovascular Disease
linkedct:org_study_id R-08-259
linkedct:overall_contact_email margaret.watson@lhsc.on.ca
linkedct:overall_contact_last_name Margaret Watson, RN
linkedct:overall_contact_phone 519 685 8500
linkedct:overall_contact_phone_ext 56111
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/8825>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/415>
foaf:page <http://clinicaltrials.gov/show/NCT00934570>
linkedct:phase Phase 4
linkedct:primary_completion_date April 2012
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/35983>
linkedct:secondary_id 15590
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/55001>
linkedct:source Lawson Health Research Institute
linkedct:start_date April 2009
linkedct:study_design Prevention, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date September 2009