NL-OMON39499已完成3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17(—)
入选标准
- •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.
排除标准
- •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.
研究者
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An efficacy, safety and pharmacokinetic study on the short-term and long-term use of METFORMIN in obese children and adolescentsobese children and adolescents of Caucasian descent with insulin resistance in the age of = 10 and = 16 years at study entry.EUCTR2010-023980-17-NLSt. Antonius Hospital
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