Effect of Bariatric Surgery Versus Medical Therapy on Metabolic Syndrome

Status Recruiting

Clinical 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). 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05363059
Study type	Observational [Patient Registry]
Source	Third Military Medical University
Contact
Status	Recruiting
Phase
Start date	May 1, 2010
Completion date	May 30, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Bariatric Surgery Versus Medical Therapy on Metabolic Syndrome — EBSMTMS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms