Metabolic SyndromeEBSMTMSNCT05363059
Effect of Bariatric Surgery Versus Medical Therapy on Metabolic Syndrome
An observational study of Metabolic Syndrome, run by Third Military Medical University at 1 site in China.
Trial summary
Bariatric surgery (BS) is known to improve the components of metabolic syndrome (MS) in obese patients. However, few studies have evaluated the impact of bariatric surgery versus medical therapy (MT) in patients with MS, especially in patients with low body mass index (BMI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Hypoglycemic drugs and Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2010to 30 Dec 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent bariatric surgery or medical therapy for metabolic syndrome between 2010 and 2020 at our institution.
- Inclusion Criteria:
- BMI<35 kg/m^2
- Underwent bariatric surgery or medical therapy
- Patients met the diagnostic criteria for MS, defined criteria derived from the joint interim statement (JIS)
- Exclusion Criteria:
- Patients who failed to follow up
- Insulin dependent diabetes
- congenital dementia
- brain trauma
- epileps
- severe hypoglycemic coma
- cerebrovascular disease
- ischemic
- heart disease
- renal dysfunction
- alcohol abuse
- mental illness
- psychoactive substance abuse
- unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Stryker Laparoscopy
Chongqing, Chongqing Municipality, 400042
Gang Ke, master, 18983286542, 494086589@qq.com
Mei Zhou, master, 18580718470, zhouxunmei_ms@163.com
About this study
Official title: Army Medical University
Bariatric surgery (BS) is known to improve the components of metabolic syndrome (MS) in obese patients. However, few studies have evaluated the impact of bariatric surgery versus medical therapy (MT) in patients with MS, especially in patients with low body mass index (BMI). This study aimed to assess the effect of bariatric surgery on MS in patients with low BMI by comparing BS (BMI<35 kg/m2 and BMI≥35 kg/m2) with MT (BMI<35 kg/m2). A retrospective study including patients with MS undergoing bariatric surgery and medical therapy at a single institution. We follow up the 5 years effect of bariatric surgery versus medical therapy on the remission of MS, its individual components, atherosclerotic cardiovascular disease (ASCVD) risk, and medication used.
Read the detailed description
- Study design and patients This study aimed to compare bariatric surgery(BS) with medical therapy (MT) for the management of low BMI patients with MS, approved by the ethics committee and institutional review at our hospital. 100 patients underwent bariatric surgery and 100 patients receiving medical therapy for obesity and type 2 diabetes between 2010 and 2020 at our institution. All patients met the Chinese guidelines developed by the Chinese Society for Metabolic \& Bariatric surgery (CSMBS). All patients achieve diagnostic criteria for MS, defined by the presence of at least 3 of the 5 following criteria derived from the joint interim statement (JIS) definition.
- outcome and Data collection All patients follow up the change of improvement in MS and its components following bariatric surgery and medical therapy, including waist circumference, hyperglycemia, hypertension, hyperlipidemia, long-term CVD risk, and medication use
- Treatments
3.1 BS group The bariatric surgical procedures performed included Roux-en-Y gastric bypass and sleeve gastrectomy.
3.2 MT group According to the guidelines in China, patients in the medical therapy group received glucose-lowering, lipid-lowering, and antihypertensive medications, with the following targets: glycosylated hemoglobin<7%; systolic blood pressure<140 mmHg, diastolic blood pressure<80 mmHg; low-density lipoprotein cholesterol<2.6 mmol/L; and high-density lipoprotein cholesterol>1.3 mmol/L for female or 1.0 mmol/L for male.
- Conditions
- Metabolic Syndrome
- Being tested
- Hypoglycemic drugs, Bariatric surgery
- Keywords
- metabolic syndrome, Medical therapy, Bariatric surgery, body mass index
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoglycemic drugsDrug
Also called antihypertensive drugs, lipid-lowering drugs
drug
Bariatric surgeryProcedure or surgery
Also called metabolic surgery
surgery
| Study group | Role | What they receive |
|---|---|---|
| BS group | The group of bariatric surgery therapy in metabolic syndrome patients. Receives: Procedure: Bariatric surgery | |
| MT group | The group of medical therapy in metabolic syndrome patients Receives: Drug: Hypoglycemic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in metabolic parameters from baseline to 5 years.
Waist circumference(cm)
Measured: baseline to 5 years
Change in metabolic parameters from baseline to 5 years.
body mass index(kg/m^2)
Measured: baseline to 5 years
Secondary outcomes (7)
Change in glycosylated hemoglobin from baseline to 5 years.
glycosylated hemoglobin(%)
Measured: baseline to 5 years
Change in plasma glucose from baseline to 5 years.
Fasting plasma glucose(mmol/l),
Measured: baseline to 5 years
Change in blood lipids from baseline to 5 years.
total cholesterol(mmol/l), triglycerides(mmol/l), high-density lipoprotein cholesterol(mmol/l), low-density lipoprotein cholesterol(mmol/l)
Measured: baseline to 5 years
Changes of CVD risk
10-year and lifetime ASCVD risk calculated by the China-PAR equation. Evaluation metrics include sex, age, region of residence (South or North), waist circumference, total cholesterol, HDL cholesterol, systolic blood pressure, diastolic blood pressure, whether taking antihypertensive drugs, whether diabetic, whether smoker, family history of cardiovascular and cerebrovascular.
Measured: baseline to 5 years
Hypoglycemic drugs use
The number and daily drug dose of hypoglycemic drugs
Measured: baseline to 5 years
Antihypertensive drugs use
The number and daily drug dose of antihypertensive drugs
Measured: baseline to 5 years
Lipid-lowering drugs use
The number and daily drug dose of lipid-lowering drugs
Measured: baseline to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 May 2010
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (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.
- 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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiming Zhu, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363059
- Sponsor's protocol ID
- EBSMTMS
- Acronym
- EBSMTMS
- Status last verified
- Aug 2024
- First submitted
- 18 Apr 2022
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Army Medical University
- ClinicalTrials.gov ID
- NCT05363059
- Acronym / sponsor ID
- EBSMTMS / EBSMTMS
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, Medical therapy, Bariatric surgery, body mass index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2010 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 5 May 2022 (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.
Bariatric surgery (BS) is known to improve the components of metabolic syndrome (MS) in obese patients. However, few studies have evaluated the impact of bariatric surgery versus medical therapy (MT) in patients with MS, especially in patients with low body mass index (BMI). This study aimed to assess the effect of bariatric surgery on MS in patients with low BMI by comparing BS (BMI<35 kg/m2 and BMI≥35 kg/m2) with MT (BMI<35 kg/m2). A retrospective study including patients with MS undergoing bariatric surgery and medical therapy at a single institution. We follow up the 5 years effect of bariatric surgery versus medical therapy on the remission of MS, its individual components, atherosclerotic cardiovascular disease (ASCVD) risk, and medication used.
Detailed description
- Study design and patients This study aimed to compare bariatric surgery(BS) with medical therapy (MT) for the management of low BMI patients with MS, approved by the ethics committee and institutional review at our hospital. 100 patients underwent bariatric surgery and 100 patients receiving medical therapy for obesity and type 2 diabetes between 2010 and 2020 at our institution. All patients met the Chinese guidelines developed by the Chinese Society for Metabolic \& Bariatric surgery (CSMBS). All patients achieve diagnostic criteria for MS, defined by the presence of at least 3 of the 5 following criteria derived from the joint interim statement (JIS) definition.
- outcome and Data collection All patients follow up the change of improvement in MS and its components following bariatric surgery and medical therapy, including waist circumference, hyperglycemia, hypertension, hyperlipidemia, long-term CVD risk, and medication use
- Treatments
3.1 BS group The bariatric surgical procedures performed included Roux-en-Y gastric bypass and sleeve gastrectomy.
3.2 MT group According to the guidelines in China, patients in the medical therapy group received glucose-lowering, lipid-lowering, and antihypertensive medications, with the following targets: glycosylated hemoglobin<7%; systolic blood pressure<140 mmHg, diastolic blood pressure<80 mmHg; low-density lipoprotein cholesterol<2.6 mmol/L; and high-density lipoprotein cholesterol>1.3 mmol/L for female or 1.0 mmol/L for male.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BS group | – | Procedure: Bariatric surgeryThe group of bariatric surgery therapy in metabolic syndrome patients. |
| MT group | – | Drug: Hypoglycemic drugsThe group of medical therapy in metabolic syndrome patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent bariatric surgery or medical therapy for metabolic syndrome between 2010 and 2020 at our institution.
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 |
|---|---|---|
| Hypoglycemic drugsAlso: antihypertensive drugs, lipid-lowering drugsdrug | Drug | MT group |
| Bariatric surgeryAlso: metabolic surgerysurgery | Procedure or surgery | BS group |
Primary outcome
Change in metabolic parameters from baseline to 5 years.
Time frame: baseline to 5 years
Waist circumference(cm)
Change in metabolic parameters from baseline to 5 years.
Time frame: baseline to 5 years
body mass index(kg/m^2)
7 secondary outcomes
Change in glycosylated hemoglobin from baseline to 5 years.
Time frame: baseline to 5 years
Change in plasma glucose from baseline to 5 years.
Time frame: baseline to 5 years
Change in blood lipids from baseline to 5 years.
Time frame: baseline to 5 years
Changes of CVD risk
Time frame: baseline to 5 years
Hypoglycemic drugs use
Time frame: baseline to 5 years
Antihypertensive drugs use
Time frame: baseline to 5 years
Lipid-lowering drugs use
Time frame: baseline to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 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.
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 Third Military 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?
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: status not confirmed, as of the sponsor's last update on 20 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in metabolic parameters from baseline to 5 years. (time frame: baseline to 5 years). The study lists 2 primary outcomes in all. 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 20 Aug 2024.