Trial record 12 of 35 for:    "Spina bifida"

Metformin in Children With Motor Deficit

This study has been completed.
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven Identifier:
First received: July 18, 2008
Last updated: September 28, 2011
Last verified: September 2011

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.

Condition Intervention
Spina Bifida
Neuromuscular Diseases
Drug: Metformin
Drug: placebo

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
Official Title: Metformin in Children With Motor Deficit

Resource links provided by NLM:

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • insulin resistance [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fat [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: November 2006
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Metformin during 12 months and then 6 months Placebo
Drug: Metformin
daily 850 mg
Drug: placebo
Placebo Comparator: B
Placebo during 6 months, afterwards 12 months metformin
Drug: Metformin
daily 850 mg
Drug: placebo


Ages Eligible for Study:   8 Years to 35 Years
Genders Eligible for Study:   Both
Accepts 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:

  • Exclusion criteria were known type 1 or type 2 diabetes mellitus and contraindications to metformin therapy.
  Contacts and Locations
Please refer to this study by its identifier: NCT00720161

Leuven, Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Principal Investigator: kristina m casteels, MD Universitaire Ziekenhuizen Leuven
  More Information

Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT00720161     History of Changes
Other Study ID Numbers: ML3830
Study First Received: July 18, 2008
Last Updated: September 28, 2011
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Universitaire Ziekenhuizen Leuven:
metformin, spina bifida, duchenne, insulin resistance

Additional relevant MeSH terms:
Neuromuscular Diseases
Spinal Dysraphism
Nervous System Diseases
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 17, 2014