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Completed

NCT Number: NCT00720161

Metformin in Children With Motor Deficit

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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Key information

Conditions

Spina Bifida Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Nervous System Malformations Neural Tube Defects Neuromuscular Diseases Nutritional and Metabolic Diseases Spinal Dysraphism

Age range

8 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZLeuven

Leuven, Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

daily 850 mg

Placebo

Drug

placebo

Primary outcomes

  1. insulin resistance

    Time frame: 12 months

    changes in insulin, fasting glucose and insulin resistance after 6 months Metformine versus 6 months placebo

Secondary outcomes

  1. fat

    Time frame: 12 months

    changes in cholesterol and triglycerides after 6 months Metformine versus 6 months placebo

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Jul 22, 2008
Registry last updated
Jun 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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