Activity and Metformin Intervention in Obese Adolescents
REACH
Reduction of Adolescent Risk Factors for Type 2 Diabetes and Cardiovascular Disease
2 other identifiers
interventional
60
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 obesity
Started Apr 2009
Typical duration for phase_4 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 6, 2009
CompletedFirst Posted
Study publicly available on registry
July 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedOctober 4, 2012
October 1, 2012
3.1 years
July 6, 2009
October 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in BMI
2 years
Secondary Outcomes (1)
Improvement in physical activity
2 years
Study Arms (4)
Metformin, Standard exercise
ACTIVE COMPARATORLifestyle intervention with metformin and standard exercise program.
Placebo, Standard exercise
PLACEBO COMPARATORLifestyle intervention with placebo and standard exercise program
Metformin, Intensive exercise
ACTIVE COMPARATORLifestyle intervention with metformin and intensive exercise
Placebo, Intensive exercise
PLACEBO COMPARATORLifestyle intervention with placebo and intensive exercise program.
Interventions
Metformin 1500 mg daily for 2 years
Metformin 1500 mg daily for 2 years
Eligibility Criteria
You may qualify if:
- Obese adolescents defined as BMI greater than the 95th percentile for age and gender
- Metformin naive subjects
You may not qualify if:
- Elevated fasting plasma glucose ≥ 6.0 mmol/L
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital, London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Related Publications (2)
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.
PMID: 27433488DERIVEDWilson 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.
PMID: 19943971DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheril Clarson, MD
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Cheril Clarson
Study Record Dates
First Submitted
July 6, 2009
First Posted
July 8, 2009
Study Start
April 1, 2009
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
October 4, 2012
Record last verified: 2012-10