Metformin in Children With Motor Deficit

Not Applicable

Completed

• Conditions: Spina Bifida; Neuromuscular Diseases
• Interventions: Drug: Metformin; Drug: Placebo

• Registration Number: NCT00720161
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2008-07-18
• Study First Submitted QC: 2008-07-21
• Study First Posted: 2008-07-22
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-09
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Patients with neurogenic or myogenic motor deficit, clinically obese or who had excessively gained weight over the last year.

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Exclusion Criteria

• Exclusion criteria were known type 1 or type 2 diabetes mellitus and contraindications to metformin therapy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B: Placebo during 6 months, afterwards 12 months metformin	Placebo	Placebo during 6 months, afterwards 12 months metformin
A: Metformin during 12 months and then 6 months Placebo	Placebo	Metformin during 12 months and then 6 months Placebo
A: Metformin during 12 months and then 6 months Placebo	Metformin	Metformin during 12 months and then 6 months Placebo
B: Placebo during 6 months, afterwards 12 months metformin	Metformin	Placebo during 6 months, afterwards 12 months metformin

Primary Outcome Measures

Name	Time	Method
insulin resistance	12 months	changes in insulin, fasting glucose and insulin resistance after 6 months Metformine versus 6 months placebo

Secondary Outcome Measures

Name	Time	Method
fat	12 months	changes in cholesterol and triglycerides after 6 months Metformine versus 6 months placebo

Trial Locations

Locations (1)

UZLeuven; 🇧🇪 Leuven, Brabant, Belgium