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NCT Number: NCT06645730

Metabolomics Predictors for 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Metabolic Syndrome Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hypertension

Diagnostic Test

diagnosed with hypertension

diabetes

Diagnostic Test

diagnosed with diabetes

fatty liver

Diagnostic Test

diagnosed with fatty liver on CT

Primary outcomes

  1. Metabolic disease remission

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 17, 2024
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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