Back to results

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

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

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

NCT ID

NCT00720161

First Posted

July 18, 2008

Last Updated

September 28, 2011

Sponsor

Universitaire Ziekenhuizen KU Leuven

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

Arm Type

Active Comparator

Arm Description

Metformin during 12 months and then 6 months Placebo

Arm Title

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

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.

Results Reference

background

Learn more about this trial

Metformin in Children With Motor Deficit

We'll reach out to this number within 24 hrs