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Fat Metabolites and Gut Hormones

2017年7月24日 更新者：Christoffer Martinussen、Hvidovre University Hospital

Effects of Fat Metabolites on Gut Hormone Secretion After Gastric Bypass Surgery

To investigate the effects of different fat metabolites on gut hormone secretion in gastric bypass operated subjects and BMI-matched controls.

研究概览

地位

未知

条件

干预/治疗

详细说明

Dietary triglycerides are hydrolyzed during digestion to two fatty acids and one 2-monoacyl glycerol. The study will investigate the effects of these different fat components on gut hormone secretion in gastric bypass operated patients and non-operated BMI-matched controls.

研究类型

介入性

注册 (预期的)

20

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

  • 丹麦
      • Hvidovre、丹麦、2650
        • Dept. of Endocrinology

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 70年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Gastric bypass operated patients:

Inclusion Criteria:

  • Uncomplicated gastric bypass surgery performed minimum 12 months prior to study

Exclusion Criteria:

  • Type 1 or 2 diabetes mellitus prior to or after gastric bypass surgery
  • Pregnancy or breastfeeding
  • Haemoglobin levels below 6,5 mM
  • Gall bladder removal

Healthy control subjects:

Exclusion Criteria:

  • Bariatric surgery or complicated upper abdominal surgery
  • Gall bladder removal
  • Pregnancy or breastfeeding
  • Haemoglobin levels below 6,5 mM
  • Co-morbidities or medicine significantly affecting glucose metabolism or appetite regulation

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：基础科学
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：10 gastric bypass operated patients
3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.
膳食补充剂：C-8 dietary oil
Ingestion of 13.15 g C-8 dietary oil providing 0.0216 mol of triglycerides.
膳食补充剂：Tricaprylin
Ingestion of 10.17 g tricaprylin providing 0.0216 mol of triglycerides.
膳食补充剂：Olive oil
Ingestion of 19 g olive oil providing 0.0216 mol of triglycerides.
实验性的：10 healthy control subjects
3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.
膳食补充剂：C-8 dietary oil
Ingestion of 13.15 g C-8 dietary oil providing 0.0216 mol of triglycerides.
膳食补充剂：Tricaprylin
Ingestion of 10.17 g tricaprylin providing 0.0216 mol of triglycerides.
膳食补充剂：Olive oil
Ingestion of 19 g olive oil providing 0.0216 mol of triglycerides.

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
Within group difference in glucagon-like peptide-1 (GLP-1) secretion (evaluated by AUC above basal).
大体时间：0-240 min following fat ingestion.
Comparison of the GLP-1 responses (evaluated by AUC above basal) induced by the different oils.
0-240 min following fat ingestion.
Within group difference in Gastric Inhibitory Peptide (GIP) secretion (evaluated by AUC above basal).
大体时间：0-240 min following fat ingestion.
Comparison of the GIP responses (evaluated by AUC above basal) induced by the different oils.
0-240 min following fat ingestion.
Within group difference in cholecystokinin (CCK) secretion (evaluated by AUC above basal).
大体时间：0-240 min following fat ingestion.
Comparison of the CCK responses (evaluated by AUC above basal) induced by the different oils.
0-240 min following fat ingestion.

次要结果测量

结果测量
措施说明
大体时间
Between group comparison of GLP-1 secretion (evaluated by AUC above basal).
大体时间：0-240 min following fat ingestion.
GLP-1 secretion (evaluated by AUC above basal) in gastric bypass operated patients compared to BMI-matched control subjects for each of the oils.
0-240 min following fat ingestion.
Between group comparison of GIP secretion (evaluated by AUC above basal).
大体时间：0-240 min following fat ingestion.
GIP secretion (evaluated by AUC above basal) in gastric bypass operated patients compared to BMI-matched control subjects for each of the oils.
0-240 min following fat ingestion.
Between group comparison of CCK secretion (evaluated by AUC above basal).
大体时间：0-240 min following fat ingestion.
GIP secretion (evaluated by AUC above basal) in gastric bypass operated patients compared to BMI-matched control subjects for each of the oils.
0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of insulin within and between groups.
大体时间：0-240 min following fat ingestion.
0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of C-peptide within and between groups.
大体时间：0-240 min following fat ingestion.
0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of peptide YY (PYY) within and between groups.
大体时间：0-240 min following fat ingestion.
0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of oxyntomodulin within and between groups.
大体时间：0-240 min following fat ingestion.
0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of glucagon within and between groups.
大体时间：0-240 min following fat ingestion.
0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of bile acids within and between groups.
大体时间：0-240 min following fat ingestion.
0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of fibroblast growth factor 19 (FGF-19) within and between groups.
大体时间：0-240 min following fat ingestion.
0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of lipid metabolites (triglyceride, cholesterol, fatty acids) within and between groups.
大体时间：0-240 min following fat ingestion.
0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of neurotensin within and between groups.
大体时间：0-240 min following fat ingestion.
0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of glucose within and between groups.
大体时间：0-240 min following fat ingestion.
0-240 min following fat ingestion.
Between group comparison of differences in GLP-1 secretion (evaluated by AUC above basal).
大体时间：0-240 min following fat ingestion.
Differences in GLP-1 secretion (evaluated by AUC above basal) induced by the different oils in gastric bypass operated patients compared with differences in BMI-matched control subjects.
0-240 min following fat ingestion.
Between group comparison of differences in GIP secretion (evaluated by AUC above basal).
大体时间：0-240 min following fat ingestion.
Differences in GIP secretion (evaluated by AUC above basal) induced by the different oils in gastric bypass operated patients compared with differences in BMI-matched control subjects.
0-240 min following fat ingestion.
Between group comparison of differences in CCK secretion (evaluated by AUC above basal).
大体时间：0-240 min following fat ingestion.
Differences in CCK secretion (evaluated by AUC above basal) induced by the different oils in gastric bypass operated patients compared with differences in BMI-matched control subjects.
0-240 min following fat ingestion.

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。

赞助

Hvidovre University Hospital

合作者

University of Copenhagen

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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 (预期的)

2017年8月7日

初级完成 (预期的)

2018年12月1日

研究完成 (预期的)

2018年12月1日

研究注册日期

首次提交

2017年7月18日

首先提交符合 QC 标准的

2017年7月18日

首次发布 (实际的)

2017年7月21日

研究记录更新

最后更新发布 (实际的)

2017年7月26日

上次提交的符合 QC 标准的更新

2017年7月24日

最后验证

2017年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CM-FAT-17

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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2型糖尿病的临床试验

C-8 dietary oil的临床试验

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赞助者和合作者

医疗条件

药物干预

CROs by country

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

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