EUCTR2004-003816-47-DE进行中（未招募）1 期
Clinical pilot study on the effect of Metformin in adipose children and adolescents with insulin-resistanceKlinische Pilotstudie zur Untersuchung der Wirkung von Metformin bei adipösen Kindern und Jugendlichen mit Insulin-Resistenz (IR) - not available
Pädiatrische Endokrinologie, Universitätsmedizin Berlin, Charité0 个研究点开始时间: 2005年10月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age from 10 to 17 years
- •BMI > 95. percentile (based on reference percentile according to AGA)
- •Ineffective multidisciplinary treatment of adiposity for at least 6 months
- •In females: highly effective method of birth control used consistently and correctly (e.g. oral contraceptives, see protocol)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
排除标准
- •Diabetes mellitus (according to criteria of the WHO)
- •Decrease in BMI > -2 within 6 months
- •Elevation of GOT and GPT Serum levels (> 150% of the upper referential value)
- •Elevation of Creatinine Serum levels
- •Decrease of Creatinine-clearance
- •All contraindications to Metformin hydrochloride (see protocol)
- •In females: sexual activity and contraindication for oral contraceptives
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