EUCTR2007-004515-56-AT进行中(未招募)1 期
Efficacy of ursodeoxycholic acid in the treatment of insulin resistance and vascular dysfunction in non-alcoholic fatty liver disease
Klinische Abteilung für Gastroenterologie und Hepatologie, Medizinische Universitätsklinik, MUG0 个研究点目标入组 110 人开始时间: 2008年3月25日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 110
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
- •- MS (NCEP ATP III): at least 3 of 5 risk factors (waist circumference in men >102 cm,
- •waist circumference in women >88 cm; triglycerides >150 mg/dL; HDL-C in men <40
- •mg/dL, HDL-C in women <50 mg/dL; blood pressure >130/85 mmHg or treated
- •hypertension; fasting glucose >110 mg/dL or treated diabetes mellitus)
- •- Diagnosis of NAFLD defined by the following criteria: alcohol consumption less than
- •30 g per day, liver histology compatible with NAFLD (steatosis more than 30% of
- •liver parenchyma)
- •- Male or female gender
- •- Age 18-70 years
- •- Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Malignancy within the last five years
- •- Chronic liver disease other than NAFLD (viral hepatitis, autoimmune liver disease,
- •hemochromatosis, homozygous alpha1-antitrypsin deficiency and Wilson disease)
- •- Drug-treated diabetes (insulin or other anti-diabetic drugs), end-organ damage
- •due to diabetes (e.g. proliferative retinopathy, renal glomerulosclerosis)
- •- BMI >40 kg/m2
- •- Inability or contraindications to perform study procedures
- •- Participation to other clinical trials in the previous 3 months
- •- Mycardial infarction in 6 months prior to enrollment
- •- Cerebrovascular events in 6 months prior to enrollment
研究者
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