Metformin in Children With Motor Deficit

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Spina Bifida; Neuromuscular Diseases

Treatments: Drug: Placebo; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT00720161

ML3830

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 8 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

A: Metformin during 12 months and then 6 months Placebo

Active Comparator group

Description:

Metformin during 12 months and then 6 months Placebo

Treatment:

Drug: Metformin

Drug: Placebo

B: Placebo during 6 months, afterwards 12 months metformin

Placebo Comparator group

Description:

Placebo during 6 months, afterwards 12 months metformin

Treatment:

Drug: Metformin

Drug: Placebo