跳至主要内容
临床试验/NCT05000996
NCT05000996招募中不适用

The Gut Microbiota in Metabolic Surgery: A Multi-Ethnic, Multi-Omic, Longitudinal Study

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年8月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Estimated 10-year risk of atherosclerotic cardiovascular disease

研究概览

简要总结

Metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes. Longitudinal studies that examined pre- to post-surgery changes in gut microbiota and its relation to cardiometabolic health after surgery are limited. Furthermore, few studies have included African Americans, a population with high rates of cardiometabolic diseases. The investigators aim to fill these research gaps by establishing a longitudinal, observational study of metabolic surgery patients and applying multi-omics to identify stool, blood, and/or tissue microbial features related to post-surgery cardiometabolic outcomes. In the current study, the investigators plan to enroll up to 300 patients who undergo metabolic surgery at Vanderbilt University Medical Center and follow them for up to 10 years after surgery. Fasting blood and stool samples will be collected at pre-surgery and 3-month, 1-year, 2-year, and 3-year post-surgery clinical visits. Tissue samples (e.g., biopsies of the liver and adipose and remnants of the stomach) will be collected during operation. Meanwhile, participants will complete a REDCap survey at baseline and 1-year, 2-year, and 3-year post-surgery. Participants' electronic medical records will be used to obtain additional information and facilitate long-term follow-up. The investigators will evaluate pre- to post-surgery changes in the fecal microbiome and fecal and blood levels of metabolites and proteins and the associations of microbiome, metabolites, and proteins with cardiometabolic improvements after surgery. This study will advance our understanding of the role of gut microbiota in metabolic surgery, which may translate into novel approaches to identify and treat obese patients for better cardiometabolic health.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be approved and scheduled for metabolic surgery at the Vanderbilt University Medical Center
  • Have a history of type 2 diabetes, hypertension, or dyslipidemia
  • Be able and willing to provide personal information and biological samples needed for the study

排除标准

  • Prior gastric operations
  • A history of coronary artery disease, stroke, heart failure, HIV infection, or untreated viral hepatitis
  • Chemotherapy or radiotherapy for cancer within 2 years
  • Current inflammatory bowel disease or celiac disease
  • Vomiting, constipation, or diarrhea within 7 days or use of antibiotics within 2 months

结局指标

主要结局

Estimated 10-year risk of atherosclerotic cardiovascular disease

时间窗: From before surgery to 1 to 3-year after surgery to 10-year after surgery

The 10-year risk of atherosclerotic cardiovascular disease based on the American College of Cardiology/American Heart Association pooled cohort equations, incorporating age, sex, race, systolic blood pressure, total cholesterol, HDL cholesterol, diabetes status, hypertension status, and smoking

次要结局

  • Blood pressure(From before surgery to 1 to 3-year after surgery to 10-year after surgery)
  • Glycated hemoglobin(From before surgery to 1 to 3-year after surgery to 10-year after surgery)
  • Blood inflammatory proteins(From before surgery to 1 to 3-year after surgery to 10-year after surgery)
  • Blood cholesterol(From before surgery to 1 to 3-year after surgery to 10-year after surgery)

研究者

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

Danxia Yu

Associate Professor of Medicine

Vanderbilt University Medical Center

研究点 (1)

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