Metformin in Children With Motor Deficit
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Spina Bifida Neuromuscular Diseases |
Intervention | Drug: Metformin Drug: placebo |
Phase | N/A |
Sponsor | Universitaire Ziekenhuizen Leuven |
Responsible Party | Universitaire Ziekenhuizen Leuven |
ClinicalTrials.gov Identifier | NCT00720161 |
First Received | July 18, 2008 |
Last Updated | September 28, 2011 |
Last verified | September 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | July 18, 2008 |
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Last Updated Date | September 28, 2011 |
Start Date | November 2006 |
Estimated Primary Completion Date | July 2011 |
Current Primary Outcome Measures | insulin resistance [Time Frame: 18 months] [Designated as safety issue: No] |
Current Secondary Outcome Measures | fat [Time Frame: 18 months] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | Metformin in Children With Motor Deficit |
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Official Title | Metformin in Children With Motor Deficit |
Brief Summary | 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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition |
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Intervention | Drug: Metformin daily 850 mg Drug: placebo placebo |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 42 |
Estimated Completion Date | July 2011 |
Estimated Primary Completion Date | July 2011 |
Eligibility Criteria | 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. |
Gender | Both |
Ages | 8 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Belgium |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00720161 |
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Other Study ID Numbers | ML3830 |
Has Data Monitoring Committee | Yes |
Information Provided By | Universitaire Ziekenhuizen Leuven |
Study Sponsor | Universitaire Ziekenhuizen Leuven |
Collaborators | Not Provided |
Investigators | Principal Investigator: kristina m casteels, MD Universitaire Ziekenhuizen Leuven |
Verification Date | September 2011 |
Locations[ + expand ][ + ]
UZLeuven | Leuven, Brabant, Belgium, 3000 |
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