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临床试验/NCT03176615
NCT03176615已完成不适用

Meal-induced Thrombin Generation in Obese Women and Men Before and After Gastric Bypass - a Model of Intentional Weight Loss

Esbjerg Hospital - University Hospital of Southern Denmark2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Postprandial peak mean of prothrombin fragment 1+2 concentrations

研究概览

简要总结

The purpose of this study is to investigate harmful effects of intentional weight loss. Intentional weight loss has been linked to increased risk of cardiovascular disease in overweight individuals, but the link between intentional weight loss and thrombotic disease is poorly understood. Postprandial coagulation activation, including thrombin generation, is a potential mechanism after high-fat meals. Thirty obese patients admitted to gastric bypass will be included in a randomized, cross-over clinical trial. All patients will consume a high-fat meal and a low-fat meal served in a randomized order on two study days (two to seven days apart). This cross-over study will be carried out before weight loss, during lifestyle-induced weight loss, and during weight loss 3-4 months after gastric bypass. Fasting and postprandial blood samples are collected on each study days, while one fecal sample is collected for each study period. The study will contribute to our understanding of mechanisms underlying harmful effects of weight loss, and future, dietary guidelines in relation to intentional weight loss programs must be modified.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible for gastric bypass surgery

排除标准

  • Use of anticoagulants, platelet inhibitors and oral contraceptives
  • Known liver diseases, any malignant disorders, or known coagulation diseases

结局指标

主要结局

Postprandial peak mean of prothrombin fragment 1+2 concentrations

时间窗: Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.

Blood samples are collected after high-fat and low-fat meals on two study days.

次要结局

  • Postprandial peak mean of cardiovascular risk markers concentrations(Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.)
  • Laboratory tests of fecal samples(Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.)

研究者

发起方
Esbjerg Hospital - University Hospital of Southern Denmark
申办方类型
Other
责任方
Principal Investigator
主要研究者

Line Espenhain Landgrebe

Principal Investigator

Esbjerg Hospital - University Hospital of Southern Denmark

研究点 (2)

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