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Enrolling by invitationNCT06707714MetabolomicsUpdated Nov 27, 2024

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

An observational study in Metabolic Syndrome and Gastric Cancer, sponsored by Dong Peng. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by Dong Peng · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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

02

Conditions studied

  • Metabolic Syndrome
  • Gastric Cancer

Keywords

  • Gastric cancer
  • Metabolic Syndrome
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 150 is below the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Dong Peng is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients with gastric cancer

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • Gastric cancer patients combine with hypertension

    Gastric cancer patients diagnosed with hypertension

    Diagnostic Test: hypertension

  • Gastric cancer patients combine with diabetes

    Gastric cancer patients diagnosed with diabetes

    Diagnostic Test: diabetes

  • Gastric cancer patients combine with fatty liver

    Gastric cancer patients diagnosed with fatty liver

    Diagnostic Test: fatty liver

Interventions

  • Diagnostic testhypertension

    Gastric cancer patients with hypertension

  • Diagnostic testdiabetes

    diagnosed with diabetes

  • Diagnostic testfatty liver

    diagnosed with fatty liver

06

What researchers measure

Primary outcomes

  1. Metabolic disease remission

    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.

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

07

Study locations

1 site
  • Chongqing Medical University
    Chongqing, Chongqing 420006, China
08

References and documents

Publications

  • 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. PubMed 34616520 ↗
  • 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. PubMed 33515868 ↗
  • 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. PubMed 36210441 ↗
  • 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. PubMed 24618998 ↗

Individual participant data

Plan to share: No — The clinical sites of the experimental studies did not allow data sharing

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06707714
Lead sponsor
Dong Peng
Responsible party
Dong Peng (Principal Investigator, First Affiliated Hospital of Chongqing Medical University) — Sponsor-investigator
First posted
Nov 27, 2024
Start date
Jul 1, 2023
Primary completion
Jul 1, 2026 (estimated)
Completion
Jul 1, 2026 (estimated)
Last update
Nov 27, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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