NL-OMON39499
Completed
Phase 3
An efficacy, safety and pharmacokinetic study on the short-term and long-term use of METFORMIN in obese children and adolescents. - Metformin in obese children and adolescents
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Bariatrie (Obesitas)
- Sponsor
- Sint Antonius Ziekenhuis
- Enrollment
- 144
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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/or parents/caregivers.
Exclusion Criteria
- •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; psychiatric illness and eating disorders in particular; 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\<80ml/min and ALAT \>\= 150% of normal value for age); use of ritonavir; use of ACE inhibitors; insufficient knowledge of the Dutch language.
Outcomes
Primary Outcomes
Not specified
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