Metformin in Children With Motor Deficit

Overview[ - collapse ][ - ]

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.
ConditionSpina Bifida
Neuromuscular Diseases
InterventionDrug: Metformin
Drug: placebo
PhaseN/A
SponsorUniversitaire Ziekenhuizen Leuven
Responsible PartyUniversitaire Ziekenhuizen Leuven
ClinicalTrials.gov IdentifierNCT00720161
First ReceivedJuly 18, 2008
Last UpdatedSeptember 28, 2011
Last verifiedSeptember 2011

Tracking Information[ + expand ][ + ]

First Received DateJuly 18, 2008
Last Updated DateSeptember 28, 2011
Start DateNovember 2006
Estimated Primary Completion DateJuly 2011
Current Primary Outcome Measuresinsulin resistance [Time Frame: 18 months] [Designated as safety issue: No]
Current Secondary Outcome Measuresfat [Time Frame: 18 months] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleMetformin in Children With Motor Deficit
Official TitleMetformin in Children With Motor Deficit
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition
  • Spina Bifida
  • Neuromuscular Diseases
InterventionDrug: Metformin
daily 850 mg
Drug: placebo
placebo
Study Arm (s)
  • Active Comparator: A
    Metformin during 12 months and then 6 months Placebo
  • Placebo Comparator: B
    Placebo during 6 months, afterwards 12 months metformin

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment42
Estimated Completion DateJuly 2011
Estimated Primary Completion DateJuly 2011
Eligibility 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.
GenderBoth
Ages8 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesBelgium

Administrative Information[ + expand ][ + ]

NCT Number NCT00720161
Other Study ID NumbersML3830
Has Data Monitoring CommitteeYes
Information Provided ByUniversitaire Ziekenhuizen Leuven
Study SponsorUniversitaire Ziekenhuizen Leuven
CollaboratorsNot Provided
Investigators Principal Investigator: kristina m casteels, MD Universitaire Ziekenhuizen Leuven
Verification DateSeptember 2011

Locations[ + expand ][ + ]

UZLeuven
Leuven, Brabant, Belgium, 3000