Metformin in Children With Motor Deficit

NCT00720161 | Completed DMC

• 1 other identifier: ML3830
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Spina Bifida; Neuromuscular Diseases

Keywords

metformin, spina bifida, duchenne, insulin resistance

Outcome Measures

Primary Outcomes (1)

• insulin resistance

  changes in insulin, fasting glucose and insulin resistance after 6 months Metformine versus 6 months placebo

  12 months

Secondary Outcomes (1)

• fat

  12 months

Study Arms (2)

A: Metformin during 12 months and then 6 months Placebo

ACTIVE COMPARATOR

Metformin during 12 months and then 6 months Placebo

Drug: Metformin; Drug: Placebo

B: Placebo during 6 months, afterwards 12 months metformin

PLACEBO COMPARATOR

Placebo during 6 months, afterwards 12 months metformin

Drug: Metformin; Drug: Placebo

Interventions

Metformin DRUG

daily 850 mg

A: Metformin during 12 months and then 6 months Placebo; B: Placebo during 6 months, afterwards 12 months metformin

Placebo DRUG

placebo

A: Metformin during 12 months and then 6 months Placebo; B: Placebo during 6 months, afterwards 12 months metformin

Eligibility Criteria

• Age: 8 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with neurogenic or myogenic motor deficit, clinically obese or who had excessively gained weight over the last year.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZLeuven

Leuven, Brabant, 3000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 16595599 BACKGROUND

MeSH Terms

Conditions

Spinal Dysraphism; Neuromuscular Diseases; Muscular Dystrophy, Duchenne; Insulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• kristina m casteels, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 22, 2008
• Study Start: November 1, 2006
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: June 17, 2024

Record last verified: 2011-09

Locations

BE (1)