Metformin in Children With Motor Deficit

Neuromuscular Diseases Clinical Trial

Official title:

Metformin in Children With Motor Deficit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720161
• Other study ID #: ML3830
• Status: Completed
• Phase: N/A
• First received: July 18, 2008
• Last updated: September 28, 2011
• Start date: November 2006
• Est. completion date: July 2011

Study information

• Verified date: September 2011
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuromuscular Diseases
• Spina Bifida
• Spinal Dysraphism

Intervention

Drug:
• Metformin
daily 850 mg
• placebo
placebo

Locations

Country	Name	City	State
Belgium	UZLeuven	Leuven	Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin resistance		18 months	No
Secondary	fat		18 months	No