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临床试验/EUCTR2007-004515-56-AT
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:
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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

发起方
Klinische Abteilung für Gastroenterologie und Hepatologie, Medizinische Universitätsklinik, MUG

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