Effect of Bariatric Surgery Versus Medical Therapy on Metabolic Syndrome

NCT ID: NCT05363059

Last Updated: 2024-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-01

Study Completion Date

2024-12-30

Brief Summary

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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

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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.

Conditions

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Metabolic Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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BS group

The group of bariatric surgery therapy in metabolic syndrome patients.

Bariatric surgery

Intervention Type PROCEDURE

surgery

MT group

The group of medical therapy in metabolic syndrome patients

Hypoglycemic drugs

Intervention Type DRUG

drug

Interventions

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Hypoglycemic drugs

drug

Intervention Type DRUG

Bariatric surgery

surgery

Intervention Type PROCEDURE

Other Intervention Names

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antihypertensive drugs lipid-lowering drugs metabolic surgery

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zhiming Zhu

Director, Center for Hypertension and Metabolic Diseases, Department of Hypertension and Endocrinology, Daping Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stryker Laparoscopy

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Gang Ke, master

Role: primary

18983286542

Mei Zhou, master

Role: backup

18580718470

Other Identifiers

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EBSMTMS

Identifier Type: -

Identifier Source: org_study_id

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