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Metformin in Children With Motor Deficit

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ClinicalTrials.gov Identifier: NCT00720161
Recruitment Status : Completed
First Posted : July 22, 2008
Last Update Posted : September 29, 2011
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment
Spina Bifida Neuromuscular Diseases Drug: Metformin Drug: placebo

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metformin in Children With Motor Deficit
Study Start Date : November 2006
Primary Completion Date : July 2011
Study Completion Date : July 2011


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. insulin resistance [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. fat [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720161


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

Publications:
Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT00720161     History of Changes
Other Study ID Numbers: ML3830
First Posted: July 22, 2008    Key Record Dates
Last Update Posted: September 29, 2011
Last Verified: September 2011

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