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临床试验/NCT05085769
NCT05085769已完成不适用

Potential Associations Between Alterations in Gut Microbiome and Obesity-related Traits After the Bariatric Surgery

Hacettepe University0 个研究点目标入组 34 人开始时间: 2015年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
主要终点
Changes in gut microbial profiles of participants

研究概览

简要总结

This study aimed to examine the effects of obesity and bariatric surgery on gut microbiota in a Turkish population, and to contribute to the literature by bringing multi-dimensional parameters including dietary intake, metabolic and inflammatory markers. This case-control study was conducted between June 2015 and August 2019. All participants were followed during the six-month period. Face-to-face interviews and physical examinations were held, and blood and fecal samples were collected at the baseline (M0) and at the end of 3 (M3) and 6 months (M6). Dietary intakes of subjects were assessed using 24-h dietary recall method in each interview and a detailed quantitative food frequency questionnaire that involved 85 food items. Subjects were recruited to the study as three groups: 15 patients who had bariatric surgery as study group, 8 morbidly obese participants who did not have bariatric surgery as control group-1 and 11 participants who were non-obese (lean (n=5) and pre-obese (n=6)) as control group-2. All subjects in the study group had sleeve gastrectomy. Subjects in control groups were selected as age and gender matched with the participants in the study group. Individuals were excluded if (a) they were under 19 or above 65 years old, (b) they had an acute or chronic inflammatory disease, (c) they were diagnosed with infectious diseases, cancer or alcohol addiction, (d) they used antibiotics in last 3 months before the screening.

研究设计

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

入排标准

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

入选标准

  • morbidly obese participants for study and control group-1
  • non-obese participants for control group-2

排除标准

  • they were under 19 or above 65 years old,
  • they had an acute or chronic inflammatory disease,
  • they were diagnosed with infectious diseases, cancer or alcohol addiction,
  • they used antibiotics in last 3 months before the screening.

结局指标

主要结局

Changes in gut microbial profiles of participants

时间窗: 6 months

Changes in bacterial phyla and sub-phylum levels

Changes in gut bacterial biodiversity of participants

时间窗: 6 months

Changes in gut bacterial alpha and beta biodiversity of participants

次要结局

  • Changes in food intakes(6 months)
  • Changes in dietary energy and nutrient intakes(6 months)

研究者

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

Aslihan Ozdemir

Research Assistant

Hacettepe University

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