Spina BifidaNCT00720161
Metformin in Children With Motor Deficit
A study testing Metformin in people with Spina Bifida and Neuromuscular Diseases, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 35 years
- Conditions the study is for
- Spina Bifida, Neuromuscular Diseases
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2006to Jul 2011
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with neurogenic or myogenic motor deficit, clinically obese or who had excessively gained weight over the last year.
Who cannot join
- Exclusion criteria were known type 1 or type 2 diabetes mellitus and contraindications to metformin therapy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Being tested
- Metformin, Placebo
- Keywords
- metformin, spina bifida, duchenne, insulin resistance
- Medical subject headings
- Spinal Dysraphism, Neuromuscular Diseases, Muscular Dystrophy, Duchenne, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
daily 850 mg
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| A: Metformin during 12 months and then 6 months Placebo | Active comparator | Metformin during 12 months and then 6 months Placebo Receives: Drug: Metformin; Drug: Placebo |
| B: Placebo during 6 months, afterwards 12 months metformin | Placebo comparator | Placebo during 6 months, afterwards 12 months metformin Receives: Drug: Metformin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin resistance
changes in insulin, fasting glucose and insulin resistance after 6 months Metformine versus 6 months placebo
Measured: 12 months
Secondary outcomes (1)
fat
changes in cholesterol and triglycerides after 6 months Metformine versus 6 months placebo
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startNov 2006
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- kristina m casteels, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720161
- Sponsor's protocol ID
- ML3830
- Status last verified
- Sep 2011
- First submitted
- 18 Jul 2008
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1210/jc.2006-0241. Epub 2006 Apr 4.
PubMed 16595599