Meal-induced Thrombin Generation Before and After Gastric Bypass
2021年11月30日 更新者：Line Espenhain Landgrebe、Hospital of South West Jutland
Meal-induced Thrombin Generation in Obese Women and Men Before and After Gastric Bypass - a Model of Intentional Weight Loss
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.
研究概览
研究类型
介入性
注册 (实际的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Esbjerg、丹麦、6700
- Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Jutland
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Eligible for gastric bypass surgery
Exclusion Criteria:
- Use of anticoagulants, platelet inhibitors and oral contraceptives
- Known liver diseases, any malignant disorders, or known coagulation diseases
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Group A (Cross-over Group 1)
Subjects randomly assigned to two experimental diets.
This arm will receive high-fat meals first, followed by a washout period of two-seven days and then low-fat meals.
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The intervention will run concurrently with the gastric bypass treatment at the hospital.
The first intervention is carried out before weight loss, and the intervention is repeated two times concurrently with two periods of weight loss (lifestyle and gastric bypass)
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实验性的：Group B (Cross-over Group 2)
Subjects randomly assigned to two experimental diets.
This arm will receive low-fat meals first, followed by a washout period of two-seven days and then high-fat meals.
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The intervention will run concurrently with the gastric bypass treatment at the hospital.
The first intervention is carried out before weight loss, and the intervention is repeated two times concurrently with two periods of weight loss (lifestyle and gastric bypass)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postprandial peak mean of prothrombin fragment 1+2 concentrations
大体时间：Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.
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Blood samples are collected after high-fat and low-fat meals on two study days.
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Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postprandial peak mean of cardiovascular risk markers concentrations
大体时间：Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.
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Blood samples are collected after high-fat and low-fat meals on two study days.
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Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.
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Laboratory tests of fecal samples
大体时间：Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.
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Bacterial components of fecal samples
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Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Else Bladbjerg, M.Sc. PhD、Unit for Thrombosis Research, Department of Regional Health Research, Hospital of South West Jutland and University of Southern Denmark
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年9月1日
初级完成 (实际的)
2021年2月1日
研究完成 (实际的)
2021年11月30日
研究注册日期
首次提交
2017年5月29日
首先提交符合 QC 标准的
2017年6月2日
首次发布 (实际的)
2017年6月5日
研究记录更新
最后更新发布 (实际的)
2021年12月1日
上次提交的符合 QC 标准的更新
2021年11月30日
最后验证
2021年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Experimental diet的临床试验
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Rush University Medical CenterUniversity of Chicago; National Institute on Aging (NIA); Advocate Hospital System主动，不招人