Metabolomics Predictors for Metabolic Disease Remission After Metabolic Syndrome Surgery.

A Metabolomics-based Study of Predictors and Associated Mechanisms of Metabolic Disease Remission After Metabolic Syndrome Surgery.

Metabolic syndrome is a combination of several metabolic abnormalities that coexist, including obesity, insulin resistance, hypertension and dyslipidaemia. These metabolic abnormalities not only increase the risk of cardiovascular disease, but are also closely associated with metabolic diseases such as type 2 diabetes, fatty liver disease, and many types of cancer. With the prevalence of metabolic syndrome and its complications increasing year by year, how to effectively prevent and treat metabolic syndrome has become a major challenge for global public health. In recent years, metabolomics, as a high-throughput analytical technique to study metabolites in organisms, has been gradually applied to the study of metabolic syndrome and related metabolic diseases. Metabolomics can comprehensively depict the metabolic state of an organism and its dynamic changes, which provides a new perspective for revealing the pathological mechanisms of metabolic syndrome and searching for potential biomarkers. Through in-depth analysis of metabolomics data, researchers are able to better understand the complex pathological process of metabolic syndrome and provide a scientific basis for the development of personalised treatment and intervention strategies. Surgical intervention is a common treatment for patients with metabolic syndrome combined with metabolic diseases. However, postoperative metabolic status and disease remission are affected by a variety of factors, and the relevant mechanisms have not been fully clarified. Metabolomics-based approaches can systematically analyse the changes in metabolites before and after surgery, explore the key factors affecting postoperative remission, and reveal their underlying mechanisms. These studies can not only optimise the surgical treatment plan, but also provide an important theoretical basis for postoperative management.

Study Overview

• Status: Active, not recruiting
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Diagnostic test: hypertension; Diagnostic test: diabetes; Diagnostic test: fatty liver

Detailed Description

This study will include patients with a diagnosis of metabolic syndrome combined with one or more metabolic disorders (e.g., type 2 diabetes mellitus, fatty liver disease, hypertension, etc.) who are determined to be on the verge of undergoing relevant surgical procedures. Patients will be categorised into patients with comorbid hypertension, patients with comorbid diabetes mellitus and patients with comorbid fatty liver disease according to their comorbid metabolic diseases. Basic preoperative information was collected, and blood and stool were collected for hormone testing and metabolomics measurements before surgery. Comparison of metabolic disease remission after surgery was performed to evaluate the efficacy. To analyse the effects of preoperative and postoperative metabolomics and hormonal changes on metabolic disease remission in patients with metabolic syndrome.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adult patients diagnosed with metabolic syndrome and undergoing bariatric surgery at the study centre.

Description

Inclusion Criteria:

• age ≥18 years;
• diagnosis of metabolic syndrome and combination of one or more metabolic diseases (e.g., type 2 diabetes mellitus, fatty liver disease, hypertension, etc.);
• identification of impending related surgical treatment;
• willingness to participate in this study and sign an informed consent form;
• complete clinical data.

Exclusion Criteria:

• Patients suffering from other serious systemic diseases (e.g., severe heart disease, renal insufficiency, liver cirrhosis, etc.) or malignant tumours;
• patients with acute diseases such as acute infections, acute myocardial infarction, acute stroke, etc.;
• patients who are on medications that may significantly affect their metabolic status (e.g., hormonal drugs, potent immunosuppressants, etc.);
• patients who cannot ensure compliance or are unwilling to cooperate with the study requirements;
• patients with Serious psychological disease or cognitive dysfunction, unable to understand the content of the study or cooperate with the study operation;
• Incomplete clinical data.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Metabolic syndrome combined with hypertension; Metabolic syndrome patients diagnosed with hypertension.	Diagnostic test: hypertension; diagnosed with hypertension
Metabolic syndrome combined with diabetes; Metabolic syndrome patients diagnosed with diabetes.	Diagnostic test: diabetes; diagnosed with diabetes
Metabolic syndrome combined with fatty liver; Metabolic syndrome patients diagnosed with fatty liver.	Diagnostic test: fatty liver; diagnosed with fatty liver on CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: diabetes; fatty liver; metabolic syndrome; metabolomics; hypertention
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome; Metabolic Diseases
• Other Study ID Numbers: 2024-223-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No