The aim of this study is determine the efficacy and safety of Metformin as a weight reducing drug in the euglykemic, obese paediatric population.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Obesitas (obesity)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Bodyweight
Secondary outcome
Effect on the cardiovascular risk profile
Effect on the quality of life
Background summary
The aim of this study is to determine the efficacy of metformin in tackling
obesity, which is a growing problem in the pediatric population.
The study is designed as a randomised, placebo-controlled, double-blind trial,
in which we will investigate the effect of metformin on the weight of obese,
euglykemic children, as well as the effect on the cardiovascular risk profile
and quality of life.
Therapy consists of metformin usage and a diet. The use of metformin is usually
well tolerated. Possible side effects are most often of gastrointestinal
origin.
Metformin is registered in the Netherlands for prescription in children with
diabetes mellitus type 2 (ten years and older).
Study objective
The aim of this study is determine the efficacy and safety of Metformin as a
weight reducing drug in the euglykemic, obese paediatric population.
Study design
The study is a randomised, placebo-controlled, double-blind trial.
Intervention
Metfromin (glucophage 500) and a diet.
Study burden and risks
Therapy consists of metformin usage and a diet. The use of metformin is usually
well tolerated. Possible side effects are most often of gastrointestinal
origin.
Metformin is registered in the Netherlands for prescription in children with
diabetes mellitus type 2 (ten years and older).
De Run 4600
5500 MB Veldhoven
Nederland
De Run 4600
5500 MB Veldhoven
Nederland
Listed location countries
Age
Inclusion criteria
Obesity
Age 10-18 years
Exclusion criteria
Diabetes mellitus
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-005765-19-NL |
| CCMO | NL15123.015.06 |