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临床试验/NCT06710314
NCT06710314Enrolling By Invitation不适用

A Metabolomics-based Study to Explore the Mechanism of Remission of Metabolic Syndrome Radical Resection of Colorectal Cancer

Dong Peng1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
150
试验地点
1
主要终点
Metabolic disease remission

研究概览

简要总结

  1. Analysis of preoperative and postoperative metabolite changes: Through metabolomics technology, the changes of preoperative and postoperative metabolites in patients with colorectal cancer complicated with metabolic syndrome such as hypertension and diabetes were systematically analyzed, and the key metabolites related to postoperative remission were found.
  2. Explore the influencing factors of postoperative remission of metabolic syndrome: Combined with clinical data, the association between various metabolites and the degree of postoperative remission was evaluated, and the main factors affecting postoperative remission were determined.

To reveal the mechanism of the remission of metabolic syndrome after surgery: To clarify the metabolic pathways and mechanisms involved in the remission of metabolic syndrome after surgery through multi-level metabolomics analysis, and to provide a new theoretical basis for the development of tumor metabolic surgery.

详细描述

This study will continue for 2-3 years. All patients who meet the inclusion and exclusion criteria will be divided into hypertension group and diabetes group according to the type of metabolic syndrome, with 120 cases in each group. Blood and feces of all patients were collected before surgery, 3 days after surgery, 6 months after surgery, and 1 year after surgery. The collected samples will be subjected to untargeted metabolomics analysis, using NMR-IVDr technology to detect the dynamic changes of all small molecular metabolites (mainly endogenous small molecular compounds with relative molecular weight within 1000 Da) in blood and feces before and after stimulation or disturbance without bias. The differential metabolites of blood glucose, blood lipids, cholesterol, insulin, renin, aldosterone and angiotensin were screened by bioinformatics analysis, and the pathway analysis of differential metabolites was performed to reveal the potential physiological mechanism of postoperative hypertension, diabetes and other metabolic syndrome remission

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years old.
  • Patients with hypertension or diabetes for more than 1 year before surgery.
  • Patients who planned to undergo radical resection of colorectal cancer

排除标准

  • Emergency operation due to intestinal obstruction and intestinal perforation.
  • Tumor with distant metastasis.
  • Combined resection of other important organs.
  • Severe postoperative complications.
  • Patients who are using drugs that may significantly affect metabolic status (such as hormonal drugs, potent immunosuppressants, etc.).
  • Incomplete clinical data.

结局指标

主要结局

Metabolic disease remission

时间窗: From date of surgery until the date of first documented postoperative complication, assessed up to 2 months after surgery.

Metabolic disease remission was defined as any remission of hypertention, diabetes, or fatty liver measured 2 months after surgery. Hypertension remission was defined as arterial blood pressure less than 140/90 mmHg measured postoperatively in patients with preoperative comorbid hypertension. Diabetes remission was defined as fasting blood glucose less than 6 mmol/L measured postoperatively in patients with preoperative comorbid diabetes. Fatty liver remission was defined as liver function in the normal range measured by postoperative blood tests in patients with preoperative comorbid fatty liver.

次要结局

未报告次要终点

研究者

发起方
Dong Peng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dong Peng

First Affiliated Hospital of Chongqing medical university

First Affiliated Hospital of Chongqing Medical University

研究点 (1)

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