Neuromuscular Diseases Clinical Trial
Official title:
Metformin in Children With Motor Deficit
NCT number | NCT00720161 |
Other study ID # | ML3830 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2006 |
Est. completion date | July 2011 |
Verified date | September 2011 |
Source | Universitaire Ziekenhuizen KU Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Obesity with insulin resistance in the paediatric population provides an increasing challenge. Children with neurological or neuromuscular diseases are even more prone to obesity: their locomotor impairment leads to an increasingly sedentary lifestyle, a decrease in physical fitness and an increase in body fat (1-3). Obesity, in turn, can be associated with a decrease in physical fitness and a further increase in body fat. In this study we want to evaluate the effect of an insulin-sensitizer, metformin, in a group of overweight/obese patients with neurological or neuromuscular diseases. Metformin is a well-established insulin sensitizer.
Status | Completed |
Enrollment | 42 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 35 Years |
Eligibility | Inclusion Criteria: - Patients with neurogenic or myogenic motor deficit, clinically obese or who had excessively gained weight over the last year. Exclusion Criteria: - Exclusion criteria were known type 1 or type 2 diabetes mellitus and contraindications to metformin therapy. |
Country | Name | City | State |
---|---|---|---|
Belgium | UZLeuven | Leuven | Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven |
Belgium,
Srinivasan S, Ambler GR, Baur LA, Garnett SP, Tepsa M, Yap F, Ward GM, Cowell CT. Randomized, controlled trial of metformin for obesity and insulin resistance in children and adolescents: improvement in body composition and fasting insulin. J Clin Endocrinol Metab. 2006 Jun;91(6):2074-80. doi: 10.1210/jc.2006-0241. Epub 2006 Apr 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | insulin resistance | changes in insulin, fasting glucose and insulin resistance after 6 months Metformine versus 6 months placebo | 12 months | |
Secondary | fat | changes in cholesterol and triglycerides after 6 months Metformine versus 6 months placebo | 12 months |
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