Clinical trial NCT06707714: A Metabolomics-based Study to Explore the Mechanism of Remission of Metabolic Syndrome After Radical Gastrectomy
Official title: A Metabolomics-based Study to Explore the Mechanism of Remission of Metabolic Syndrome After Radical Gastrectomy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Metabolic Syndrome
Gastric Cancer
Keywords: Gastric cancer
Metabolic Syndrome
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with gastric cancer

Brief summary: 1. Analysis of preoperative and postoperative metabolite changes: Through metabolomics technology, the changes of preoperative and postoperative metabolites in patients with gastric cancer complicated with metabolic syndrome were systematically analyzed, and the key metabolites related to the remission of hypertension, hyperlipidemia, and diabetes after surgery 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.
3. Reveal the mechanism of postoperative remission of metabolic syndrome: through multi-level metabolomics analysis, to clarify the metabolic pathways and mechanisms involved in the process of postoperative remission, and provide a new theoretical basis for the development of tumor metabolic surgery.

Detailed description: This project will last 2-3 years. All patients who meet the inclusion and exclusion criteria will be divided into three groups according to the type of metabolic syndrome, including hypertension, diabetes and hyperlipidemia, with 50 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 lipid, 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 hyperlipidemia

Eligibility criteria: Inclusion Criteria:

* 1. Age \>18 years old. 2. Patients with hypertension or diabetes for more than 1 year before surgery. 3. Patients undergoing radical gastrectomy for gastric cancer.

Exclusion Criteria:

* 1. Gastric stump cancer. 2. Patients with distant metastasis. 3. Patients who underwent 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: Cheng YX, Peng D, Tao W, Zhang W. Effect of oncometabolic surgery on gastric cancer: The remission of hypertension, type 2 diabetes mellitus, and beyond. World J Gastrointest Oncol. 2021 Sep 15;13(9):1157-1163. doi: 10.4251/wjgo.v13.i9.1157.
citation: Nudotor RD, Prokopowicz G, Abbey EJ, Gonzalez A, Canner JK, Steele KE. Comparative Effectiveness of Roux-en Y Gastric Bypass Versus Vertical Sleeve Gastrectomy for Sustained Remission of Type 2 Diabetes Mellitus. J Surg Res. 2021 May;261:407-416. doi: 10.1016/j.jss.2020.12.024. Epub 2021 Jan 27.
citation: Wang L, Hu D, Fan Z, Yu J, Zhang S, Lin Y, Chen X, Lin X, Yan X, Lin J, Peng F. Prognostic value of long-term antidiabetic and antihypertensive therapy in postoperative gastric cancer patients: the FIESTA study. BMC Gastroenterol. 2022 Oct 9;22(1):429. doi: 10.1186/s12876-022-02514-4.
citation: Karimi P, Islami F, Anandasabapathy S, Freedman ND, Kamangar F. Gastric cancer: descriptive epidemiology, risk factors, screening, and prevention. Cancer Epidemiol Biomarkers Prev. 2014 May;23(5):700-13. doi: 10.1158/1055-9965.EPI-13-1057. Epub 2014 Mar 11.