drugset / Trial / NCT00934570
Activity and Metformin Intervention in Obese Adolescents
Phase 4
Completed
60 enrolled
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Canadian Institutes of Health Research (CIHR) · collab
RandomizedParallel-groupSingle-blindPrevention
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.
Timeline
- Start
- 2009-04
- Primary completion
- 2012-05
- Completion
- 2012-05
Publications
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metformin | Small molecule | 1500 mg | — |