NCT00138684已完成2 期
Cytochrome P450 2E1 and Iron Overload
Rennes University Hospital3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2003年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- variation of chlorzoxazone metabolization rate measured before and after venesection
研究概览
简要总结
The aim of the study is to determine, in patients presenting hepatic iron overload (genetic haemochtomatisis or dysmetabolic iron overload syndrome), the effects of venesection therapy on cytochrome P450 2E1 activity by comparing the rates of metabolization of chlorzoxazone before and after venesection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged from 18 to 70 years
- •Hepatic iron overload measured by magnetic resonance imaging [MRI] (> 36 µmol/g and < 200 µmol/L)
- •Homozygosity for the C282Y mutation of the HFE or dysmetabolic iron overload syndrome (DIOS) based on the presence of at least one of these following metabolic abnormalities:
- •Overweight: BMI > 25 kg/m2
- •Waist/hip circumference (cm) > 0.90
- •Diabetes mellitus (fasting blood glucose level >1.25g/L or blood glucose level after 2 hours > 2g/L) or glucose intolerance (fasting blood glucose level between 1.10 and 1.25g/L)
- •Total cholesterolemia > 6.2 mmol/L or HDL-Cholesterol < 0.9 mmol/L
- •TG>= 1.7 mmol
- •Written informed consent
- •Non-Inclusion Criteria:
- •Consumption of alcohol > 50 g/day and of any CYP2E1 inhibitor substances
- •Smoker > 5 cigarets/day
- •History of blood donation or venesection
- •Other causes of iron overload: aceruloplasminaemia, haematological disorder (abnormal blood counting), late cutaneous porphyria (cutaneous bullous disorders and photosensibilisation) , martial treatment, repeated transfusions.
- •Inflammatory syndrome (CRP > 3ng/ml)
排除标准
- 未提供
研究组 & 干预措施
no venesection therapy
No Intervention
Venesection therapy
Experimental
干预措施: venesection (Procedure)
结局指标
主要结局
variation of chlorzoxazone metabolization rate measured before and after venesection
时间窗: Baseline and after iron desaturation completion
次要结局
- variation of blood Malonedialdehyde rate(Baseline and after iron desaturation completion)
- variation of blood 4-hydroxynonenal rate(Baseline and after iron desaturation completion)
- variation of blood Glutathion rate(Baseline and after iron desaturation completion)
- variation of serum Vitamin E rate(Baseline and after iron desaturation completion)
- Variation of serum Vitamin C rate(Baseline and after iron desaturation completion)
研究者
研究点 (3)
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