Metformin in Children With Motor Deficit - Full Text View

Sponsored by:	Universitaire Ziekenhuizen Leuven
Information provided by:	Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:	NCT00720161

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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Metformin in Children With Motor Deficit

Resource links provided by NLM:

MedlinePlus related topics: Neuromuscular Disorders Obesity Obesity in Children Spina Bifida

Drug Information available for: Metformin Metformin hydrochloride

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
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Metformin during 12 months and then 6 months Placebo	Drug: Metformin daily 850 mg Drug: placebo placebo
B: Placebo Comparator 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, Brabant
UZLeuven
Leuven, Brabant, Belgium, 3000

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators

Principal Investigator:

kristina m casteels, MD

Universitaire Ziekenhuizen Leuven

More Information

Publications:

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.

Responsible Party:	UZ Leuven ( Kristina Casteels )
Study ID Numbers:	ML3830
Study First Received:	July 18, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00720161 History of Changes
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

Study placed in the following topic categories:

Neural Tube Defects
Hypoglycemic Agents
Spina Bifida
Neuromuscular Diseases
Nervous System Malformations
Spinal Dysraphism

Metformin
Insulin Resistance
Congenital Abnormalities
Neural Tube Defect, Folate-sensitive
Insulin

Additional relevant MeSH terms:

Neural Tube Defects
Hypoglycemic Agents
Neuromuscular Diseases
Nervous System Malformations
Spinal Dysraphism

Physiological Effects of Drugs
Metformin
Nervous System Diseases
Congenital Abnormalities
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 09, 2009