An efficacy, safety and pharmacokinetic study on the short-term and long-term use of METFORMIN in obese children and adolescents - Metformin study

St. Antonius Hospital0 个研究点开始时间: 2011年7月11日最近更新: 2012年3月19日

适应症

试验速览

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•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.

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