Clinical trial NCT00934570: Activity and Metformin Intervention in Obese Adolescents
Official title: Reduction of Adolescent Risk Factors for Type 2 Diabetes and Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Type 2 Diabetes
Keywords: Obesity
Metformin
Physical activity
Cardiovascular health
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2009-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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.

Eligibility 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

Primary outcomes:
measure: Reduction in BMI
timeFrame: 2 years
Secondary outcomes:
measure: Improvement in physical activity
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: Canada
facility: Children's Hospital, London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Cheril Clarson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.