Effect of Bariatric Surgery Versus Medical Therapy on Metabolic Syndrome (EBSMTMS)

August 16, 2024 updated by: Zhiming Zhu, Third Military Medical University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. 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.

  2. 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

  3. 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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • Stryker Laparoscopy
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients underwent bariatric surgery or medical therapy for metabolic syndrome between 2010 and 2020 at our institution.

Description

  1. 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)

  2. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BS group
The group of bariatric surgery therapy in metabolic syndrome patients.
Procedure: Bariatric surgery
surgery
Other Names:
  • metabolic surgery
MT group
The group of medical therapy in metabolic syndrome patients
Drug: Hypoglycemic drugs
drug
Other Names:
  • antihypertensive drugs
  • lipid-lowering drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in metabolic parameters from baseline to 5 years.
Time Frame: baseline to 5 years
Waist circumference(cm)
baseline to 5 years
Change in metabolic parameters from baseline to 5 years.
Time Frame: baseline to 5 years
body mass index(kg/m^2)
baseline to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycosylated hemoglobin from baseline to 5 years.
Time Frame: baseline to 5 years
glycosylated hemoglobin(%)
baseline to 5 years
Change in plasma glucose from baseline to 5 years.
Time Frame: baseline to 5 years
Fasting plasma glucose(mmol/l),
baseline to 5 years
Change in blood lipids from baseline to 5 years.
Time Frame: baseline to 5 years
total cholesterol(mmol/l), triglycerides(mmol/l), high-density lipoprotein cholesterol(mmol/l), low-density lipoprotein cholesterol(mmol/l)
baseline to 5 years
Changes of CVD risk
Time Frame: baseline to 5 years
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.
baseline to 5 years
Hypoglycemic drugs use
Time Frame: baseline to 5 years
The number and daily drug dose of hypoglycemic drugs
baseline to 5 years
Antihypertensive drugs use
Time Frame: baseline to 5 years
The number and daily drug dose of antihypertensive drugs
baseline to 5 years
Lipid-lowering drugs use
Time Frame: baseline to 5 years
The number and daily drug dose of lipid-lowering drugs
baseline to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2010

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

April 18, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (Actual)

May 5, 2022

Study Record Updates

Last Update Posted (Actual)

August 20, 2024

Last Update Submitted That Met QC Criteria

August 16, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBSMTMS

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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