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Metformin in Children With Motor Deficit

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00720161
First received: July 18, 2008
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

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
Placebo Comparator: B
Placebo during 6 months, afterwards 12 months metformin
 Drug: Metformin
daily 850 mg
Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   8 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00720161

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

Publications:

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov 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
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013