Metformin in Children With Motor Deficit

Brief Summary

Official Title: “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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: July 2011

Interventions Used in this Clinical Trial

  • Drug: Metformin
    • daily 850 mg
  • Drug: placebo
    • placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: A
    • Metformin during 12 months and then 6 months Placebo
  • Placebo Comparator: B
    • Placebo during 6 months, afterwards 12 months metformin

Outcome Measures for this Clinical Trial

Primary Measures

  • insulin resistance
    • Time Frame: 18 months
      Safety Issue?: No

Secondary Measures

  • fat
    • Time Frame: 18 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 8 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Universitaire Ziekenhuizen Leuven
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • kristina m casteels, MD, Principal Investigator, Universitaire Ziekenhuizen Leuven

References

Srinivasan S, Ambler GR, Baur LA, Garnett SP, Tepsa M, Yap F, Ward GM, Cowell CT. Randomized, controlled trial of metformin for obesity and insulin resistance in children and adolescents: improvement in body composition and fasting insulin. J Clin Endocrinol Metab. 2006 Jun;91(6):2074-80. Epub 2006 Apr 4.

Source

Clinical Trials content is provided directly by the US National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of information about a specific clinical trial contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00720161