A Metabolomics-based Study to Explore the Mechanism of Remission of Metabolic Syndrome After Radical Gastrectomy

• Conditions: Metabolic Syndrome; Gastric Cancer

• Registration Number: NCT06707714
• Lead Sponsor: Dong Peng

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

Study Timeline

• Study Start: 2023-07-01
• Status Verified: 2024-09
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolic disease remission	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.

Trial Locations

Locations (1)

Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China