Metabolomics Predictors for Metabolic Disease Remission After Metabolic Syndrome Surgery.

NCT06645730 | Active Not Recruiting DMC

• 1 other identifier: 2024-223-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome; metabolomics; hypertention; 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)

Metabolic syndrome combined with hypertension

Metabolic syndrome patients diagnosed with hypertension.

Diagnostic Test: hypertension

Metabolic syndrome combined with diabetes

Metabolic syndrome patients diagnosed with diabetes.

Diagnostic Test: diabetes

Metabolic syndrome combined with fatty liver

Metabolic syndrome patients diagnosed with fatty liver.

Diagnostic Test: fatty liver

Interventions

hypertension DIAGNOSTIC_TEST

diagnosed with hypertension

Metabolic syndrome combined with hypertension

diabetes DIAGNOSTIC_TEST

diagnosed with diabetes

Metabolic syndrome combined with diabetes

fatty liver DIAGNOSTIC_TEST

diagnosed with fatty liver on CT

Metabolic syndrome combined with fatty liver

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus; Fatty Liver

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 17, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)