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

NCT06710314 | Enrolling By Invitation DMC

• 1 other identifier: Chongqing Medical University
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Metabolomics

Keywords

colorectal cancer; Metabolomics; hypertension; diabetes; fatty liver

Outcome Measures

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.

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

Study Arms (3)

Diagnostic Test：Hypertension

Hypertension

Diagnostic Test: Colorectal cancer patients with hypertension

Diagnostic Test：Diabetes

Diabetes

Diagnostic Test: Colorectal cancer patients with diabetes

Diagnostic Test：fatty liver

fatty liver

Diagnostic Test: Colorectal cancer patients with fatty liver

Interventions

Colorectal cancer patients with hypertension DIAGNOSTIC_TEST

Colorectal cancer patients with hypertension

Diagnostic Test：Hypertension

Colorectal cancer patients with diabetes DIAGNOSTIC_TEST

Colorectal cancer patients with diabetes

Diagnostic Test：Diabetes

Colorectal cancer patients with fatty liver DIAGNOSTIC_TEST

Colorectal cancer patients with fatty liver

Diagnostic Test：fatty liver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Colorectal cancer complicated with metabolic syndrome such as hypertension, diabetes and fatty liver

You may qualify if:

• \. 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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Dong Peng: lead

Study Sites (1)

Chongqing medical university

Chongqing, Chongqing Municipality, 420006, China

Location

Related Publications (5)

• 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.

  PMID: 34295822 BACKGROUND

• Cheng HC, Chang TK, Su WC, Tsai HL, Wang JY. Narrative review of the influence of diabetes mellitus and hyperglycemia on colorectal cancer risk and oncological outcomes. Transl Oncol. 2021 Jul;14(7):101089. doi: 10.1016/j.tranon.2021.101089. Epub 2021 Apr 7.

  PMID: 33838541 BACKGROUND

• Petrelli F, Ghidini M, Rausa E, Ghidini A, Cabiddu M, Borgonovo K, Ghilardi M, Parati MC, Pietrantonio F, Sganzerla P, Bossi AC. Survival of Colorectal Cancer Patients With Diabetes Mellitus: A Meta-Analysis. Can J Diabetes. 2021 Mar;45(2):186-197.e2. doi: 10.1016/j.jcjd.2020.06.009. Epub 2020 Jun 20.

  PMID: 33039329 BACKGROUND

• Ricci C, Gaeta M, Rausa E, Macchitella Y, Bonavina L. Early impact of bariatric surgery on type II diabetes, hypertension, and hyperlipidemia: a systematic review, meta-analysis and meta-regression on 6,587 patients. Obes Surg. 2014 Apr;24(4):522-8. doi: 10.1007/s11695-013-1121-x.

  PMID: 24214202 BACKGROUND

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Hypertension; Diabetes Mellitus; Fatty Liver

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: First Affiliated Hospital of Chongqing medical university

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

CN (1)