Metabolic SyndromeNCT06645730
Metabolomics Predictors for Metabolic Disease Remission After Metabolic Syndrome Surgery.
An observational study of Metabolic Syndrome, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- hypertension, diabetes and fatty liver
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients diagnosed with metabolic syndrome and undergoing bariatric surgery at the study centre.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- hypertension, diabetes, fatty liver
- Keywords
- metabolic syndrome, metabolomics, hypertention, diabetes, fatty liver
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypertensionDiagnostic test
diagnosed with hypertension
diabetesDiagnostic test
diagnosed with diabetes
fatty liverDiagnostic test
diagnosed with fatty liver on CT
| Study group | Role | What they receive |
|---|---|---|
| Metabolic syndrome combined with hypertension | Metabolic syndrome patients diagnosed with hypertension. Receives: Diagnostic Test: hypertension | |
| Metabolic syndrome combined with diabetes | Metabolic syndrome patients diagnosed with diabetes. Receives: Diagnostic Test: diabetes | |
| Metabolic syndrome combined with fatty liver | Metabolic syndrome patients diagnosed with fatty liver. Receives: Diagnostic Test: fatty liver |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of surgery until the date of first documented postoperative complication, assessed up to 2 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Oct 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Peng, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645730
- Sponsor's protocol ID
- 2024-223-01
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Metabolomics-based Study of Predictors and Associated Mechanisms of Metabolic Disease Remission After Metabolic Syndrome Surgery.
- ClinicalTrials.gov ID
- NCT06645730
- Acronym / sponsor ID
- 2024-223-01
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, metabolomics, hypertention, diabetes, fatty liver
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metabolic syndrome combined with hypertension | – | Diagnostic Test: hypertensionMetabolic syndrome patients diagnosed with hypertension. |
| Metabolic syndrome combined with diabetes | – | Diagnostic Test: diabetesMetabolic syndrome patients diagnosed with diabetes. |
| Metabolic syndrome combined with fatty liver | – | Diagnostic Test: fatty liverMetabolic syndrome patients diagnosed with fatty liver. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients diagnosed with metabolic syndrome and undergoing bariatric surgery at the study centre.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypertensiondiagnosed with hypertension | Diagnostic test | Metabolic syndrome combined with hypertension |
| diabetesdiagnosed with diabetes | Diagnostic test | Metabolic syndrome combined with diabetes |
| fatty liverdiagnosed with fatty liver on CT | Diagnostic test | Metabolic syndrome combined with fatty liver |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic disease remission (time frame: From date of surgery until the date of first documented postoperative complication, assessed up to 2 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.