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临床试验/NCT03475849
NCT03475849已完成不适用

Effects of Gastric Bypass Surgery on Bile Acid Homeostasis

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Percentage of orally ingested exogenic bile acid that is retained in the body after 7 days

研究概览

简要总结

The purpose of this study is to determine whether the bile acid circulation is changed after gastric bypass surgery. Further, to account for how the changed anatomy of the gut influences how the bile acid and food is mixed in the gut and how this is associated with the changes in gut hormone release after the surgery.

Our hypothesis is that bile acid reabsorption from the gut is increased as animal models suggest so and bile acid blood concentration increases after surgery.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 25 and 65 years
  • For patients: uncomplicated Roux-en-Y Gastric Bypass surgery more than 12 months before study initiation
  • For controls: Age, BMI and gender matched with patient group

排除标准

  • Previous removal of gall bladder or other abdominal surgeries except appendectomy (and gastric bypass surgery for patient group)
  • Known liver disease or thyroid disease requiring antithyroid medication
  • Chronic gastrointestinal symptoms
  • Any chronic disease interfering with, or susceptive of interfering with appetite or gastrointestinal function
  • Any medication interfering with, or susceptive of interfering with appetite or gastrointestinal function
  • Smoking within the last month
  • Alcohol consumption above 168 grams per week
  • Currently pregnant or breast-feeding
  • Anaemia with haemoglobin <6,5 mmol/L (<117 mg/dl)
  • Loss or gain of more than 3 kg within the last 3 months

结局指标

主要结局

Percentage of orally ingested exogenic bile acid that is retained in the body after 7 days

时间窗: Patients: >12 months after Gastric Bypass Surgery

Differences in time from food intake to mix of food in the gut with bile acid between patients and controls

时间窗: Patients: >12 months after Gastric Bypass Surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carsten Dirksen

MD, PhD

Hvidovre University Hospital

研究点 (1)

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