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Gut Microbiota Post Roux-en-Y Gastric Bypass Surgery

2018年8月22日 更新者:Kristine Steffen、North Dakota State University

The Gut Microbiota in Patients Post Roux-en-Y Gastric Bypass Surgery

The purpose of this study is to investigate mechanisms responsible for weight change in patients who have undergone weight loss surgery. Specifically, we will compare the gut microbiota, plasma bile acids, plasma gut peptides (GLP-1, GLP-2, and PYY), and plasma LPS in three groups of subjects: 3-5 years post gastric bypass patients who experienced sub-optimal weight loss, 3-5 years post gastric bypass patients who had successful weight loss, and a control group who has not had a weight loss surgery and are of similar age, gender, body mass index as the gastric bypass groups.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

19

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

    • North Dakota
      • Fargo、North Dakota、美国、58103
        • North Dakota State University/Sanford Health

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 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

非概率样本

研究人群

3-5 years post gastric bypass patients and control subjects

描述

Inclusion Criteria:

  • Female
  • Age 18-65
  • 3-5 years post Roux-en-Y gastric bypass and experienced successful weight loss following surgery (up to n=10) or
  • 3-5 years post Roux-en-Y gastric bypass and did not experience optimal weight loss following surgery (up to n=10) or
  • Nonsurgical control participants who are approximately matched in sex, age, and BMI to the optimal weight loss group (up to n=10).

Exclusion Criteria:

  • Tobacco use in past three months.
  • Taking a medication which is known to significantly influence gastrointestinal transit time or affect the microbiome or other variables significantly (as determined by study pharmacist/MD).
  • History of diabetes mellitus.
  • Has taken an oral or IV/IM antibiotic in the past 3 months.
  • Has taken probiotic and/or prebiotic agent in the past 3 months
  • History of significant intestinal disease or disorder (e.g., Crohn's disease, ulcerative colitis, irritable bowel syndrome)
  • History of gastrointestinal surgery that may impact measures of biological variables, as determined by the investigator.
  • Medical condition expected to impact the biological variables of interest or interfere with providing a sample, as determined by the investigator.
  • Unable to speak/read English.
  • Breastfeeding, pregnant, or planning to become pregnant within the duration of the study.
  • Unwilling to use a medically acceptable form of contraception.
  • History of bipolar or psychotic spectrum disorder or alcohol or substance treatment in the past year

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

队列和干预

团体/队列
干预/治疗
Group 1 (Successful weight loss)
3-5 years post Roux-en-Y gastric bypass patients who had successful weight loss
Participants will receive a liquid nutritional supplement. Before and after administration, biological variables of interest will be collected.
Group 2 (Suboptimal weight loss)
3-5 years post Roux-en-Y gastric bypass patients who had suboptimal weight loss
Participants will receive a liquid nutritional supplement. Before and after administration, biological variables of interest will be collected.
Group 3 (Control group)
A control group who has not had Roux-en-Y gastric bypass surgery and are of similar age, gender, body mass index as the gastric bypass groups.
Participants will receive a liquid nutritional supplement. Before and after administration, biological variables of interest will be collected.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Intestinal Microbiome Composition. The ratio of firmicutes to bacteroidetes will be the primary focus of the microbiome evaluation.
大体时间:3-5 years post RYGB
3-5 years post RYGB

次要结果测量

结果测量
大体时间
Plasma levels of cholic acid, chenodeoxy cholic acids, deoxycholic acid, and lithocholic acid will be measured by LCMS and will be compared between successful weight loss and poor weight loss post-RYGB and control groups.
大体时间:3-5 years post RYGB
3-5 years post RYGB
Plasma levels of GLP-1, GLP-2, and PYY will be measured by ELISA and will be compared between successful weight loss and poor weight loss post-RYGB and control groups.
大体时间:3-5 years post RYGB
3-5 years post RYGB
Plasma levels of Lipopolysaccharide (LPS) will be measured by the Limulus Amebocyte Lysate (LAL) assay and will be compared between successful weight loss and poor weigh loss post-RYGB and control groups.
大体时间:3-5 years post RYGB
3-5 years post RYGB

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

  • 首席研究员:Kristine Steffen, PharmD.,Ph.D、North Dakota State University

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。

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

2016年1月1日

初级完成 (实际的)

2017年9月1日

研究完成 (实际的)

2017年12月1日

研究注册日期

首次提交

2015年12月17日

首先提交符合 QC 标准的

2016年1月12日

首次发布 (估计)

2016年1月13日

研究记录更新

最后更新发布 (实际的)

2018年8月23日

上次提交的符合 QC 标准的更新

2018年8月22日

最后验证

2018年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • IRB-201509-061

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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.

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