Clinical trial NCT06710314: A Metabolomics-based Study to Explore the Mechanism of Remission of Metabolic Syndrome Radical Resection of Colorectal Cancer
Official title: A Metabolomics-based Study to Explore the Mechanism of Remission of Metabolic Syndrome Radical Resection of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Metabolomics
Keywords: colorectal cancer
Metabolomics
hypertension
diabetes
fatty liver
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Colorectal cancer complicated with metabolic syndrome such as hypertension, diabetes and fatty liver

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 1. Age \>18 years old. 2. Patients with hypertension or diabetes for more than 1 year before surgery. 3. Patients who planned to undergo radical resection of colorectal cancer

Exclusion Criteria:

* 1. Emergency operation due to intestinal obstruction and intestinal perforation. 2. Tumor with distant metastasis. 3. Combined resection of other important organs. 4. Severe postoperative complications. 5. Patients who are using drugs that may significantly affect metabolic status (such as hormonal drugs, potent immunosuppressants, etc.). 6. Incomplete clinical data.

Primary outcomes:
measure: Metabolic disease remission
timeFrame: From date of surgery until the date of first documented postoperative complication, assessed up to 2 months after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing medical university
state: Chongqing
Study officials:
References:
citation: Peng D, Liu XY, Cheng YX, Tao W, Cheng Y. Improvement of Diabetes Mellitus After Colorectal Cancer Surgery: A Retrospective Study of Predictive Factors For Type 2 Diabetes Mellitus Remission and Overall Survival. Front Oncol. 2021 Jul 6;11:694997. doi: 10.3389/fonc.2021.694997. eCollection 2021.
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