An efficacy, safety and pharmacokinetic study on the short-term and long-term use of METFORMIN in obese children and adolescents
- Conditions
- obese children and adolescents of Caucasian descent with insulin resistance in the age of = 10 and = 16 years at study entry.Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2010-023980-17-NL
- Lead Sponsor
- St. Antonius Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
The inclusion criteria are subject’s age = 10 and = 16 years at study entry, from Caucasian descent, with obesity defined as BMI-SDS > 2.3 and with insulin resistance defined as HOMA-IR = 3.4. In addition an obtained informed consent from subjects and parents/caregivers.
Are the trial subjects under 18? yes
Number of subjects for this age range: 144
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
The exclusion criteria are presence of T2DM (American Diabetes Association criteria); presence of endocrine disorders with steroid therapy; suspicion of polycystic ovarium syndrome; height < -1.3 SD of target height; syndrome disorders with or without mental retardation; use of anti-hyperglycaemic drugs; pregnancy (pregnancy test will be performed, if applicable); (history of) alcohol abuse; impaired renal and/or hepatic function (defined as GFR < 80 ml/min. GFR= 40 x length (cm) / serumcreatinin (µmol/l), and ALAT >150% of normal value for age); use of ritonavir; use of ACE inhibitors; insufficient knowledge of the Dutch language.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method