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临床试验/EUCTR2011-000813-37-SE
EUCTR2011-000813-37-SE进行中(未招募)不适用

Effects of obeticholic acid on hepatic fatty acid/triglyceride metabolism and hepatobiliary detoxification/elimination in morbidly obese and gallstone patients. - OCABSGS

Sahlgrenska Academy0 个研究点开始时间: 2011年3月3日最近更新:
适应症

试验速览

阶段
不适用
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

  • Age20 to 65 years;
  • in the obesity group: BMI =35 kg/m2
  • in the gallstone group: symptomatic, ultrasound verified gallstone disease
  • SexMales, pre-, and post-menopausal females
  • DiagnosisPatients eligible to laparoscopic bariatric and gallstone surgery, respectively
  • ConsentPatients should have given their written consent to participate in this study
  • 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)
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Chronic liver disease other than NAFLD (viral hepatitis, autoimmune liver disease, hemochromatosis, homozygous alpha1-antitrypsin deficiency and Wilson disease)
  • Previous gastric or small bowel surgery
  • Inflammatory bowel disease
  • Uncontrolled diabetes mellitus (fasting blood glucose >6.7 mmol/L),
  • hypothyroidism or hyperthyroidism, or other significant endocrine disease (a subject who is euthyroid on a stable replacement dose of thyroid hormone is
  • acceptable provided the TSH is within normal range).
  • Other serious disease, including depressive disorders treated by medication
  • Patients who will not comply with the protocol.
  • Pregnancy. Women in childbearing age must adhere to secure anticonception

研究者

发起方
Sahlgrenska Academy

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