Neuromuscular Diseases, Spina Bifida
Conditions
Keywords
metformin, spina bifida, duchenne, insulin resistance
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.
Interventions
DRUGMetformin
daily 850 mg
DRUGPlacebo
placebo
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Patients with neurogenic or myogenic motor deficit, clinically obese or who had excessively gained weight over the last year.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| insulin resistance | 12 months | changes in insulin, fasting glucose and insulin resistance after 6 months Metformine versus 6 months placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fat | 12 months | changes in cholesterol and triglycerides after 6 months Metformine versus 6 months placebo |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATORkristina m casteels, MD
Universitaire Ziekenhuizen KU Leuven
Outcome results
None listed