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Metformin in Children With Motor Deficit

Primary Purpose

Spina Bifida, Neuromuscular Diseases

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Metformin
placebo
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spina Bifida focused on measuring metformin, spina bifida, duchenne, insulin resistance

Eligibility Criteria

8 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UZLeuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Metformin during 12 months and then 6 months Placebo

Placebo during 6 months, afterwards 12 months metformin

Outcomes

Primary Outcome Measures

insulin resistance

Secondary Outcome Measures

fat

Full Information

First Posted
July 18, 2008
Last Updated
September 28, 2011
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT00720161
Brief Title
Metformin in Children With Motor Deficit
Official Title
Metformin in Children With Motor Deficit
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spina Bifida, Neuromuscular Diseases
Keywords
metformin, spina bifida, duchenne, insulin resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Metformin during 12 months and then 6 months Placebo
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo during 6 months, afterwards 12 months metformin
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
daily 850 mg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
insulin resistance
Time Frame
18 months
Secondary Outcome Measure Information:
Title
fat
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kristina m casteels, MD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZLeuven
City
Leuven
State/Province
Brabant
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
16595599
Citation
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. doi: 10.1210/jc.2006-0241. Epub 2006 Apr 4.
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Metformin in Children With Motor Deficit

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