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

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

Drug Information available for: Insulin Metformin Metformin hydrochloride

U.S. FDA Resources

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

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
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
Neuromuscular Diseases
Nervous System Malformations
Spinal Dysraphism
Spina bifida

Metformin
Neural tube defect, folate-sensitive
Insulin Resistance
Congenital Abnormalities
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009