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Effect of Bariatric Surgery Versus Medical Therapy on Metabolic Syndrome

ConditionMetabolic Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorThird Military Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI<35 kg/m²

Underwent bariatric surgery or medical therapy

Patients met the diagnostic criteria for MS, defined criteria derived from the joint interim statement (JIS)

Disqualifiers

Patients who failed to follow up

Insulin dependent diabetes

congenital dementia

brain trauma

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Hypoglycemic drugs

    Drug

    drug

  • Bariatric surgery

    Procedure/Surgery

    surgery

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: BS group1 intervention
Group B: MT group1 intervention

Trial outcomes

Primary outcomes

1

Change in metabolic parameters from baseline to 5 years.

Waist circumference(cm)

Time frame
baseline to 5 years
2

Change in metabolic parameters from baseline to 5 years.

body mass index(kg/m\^2)

Time frame
baseline to 5 years

Secondary outcomes

1

Change in glycosylated hemoglobin from baseline to 5 years.

glycosylated hemoglobin(%)

Time frame
baseline to 5 years
2

Change in plasma glucose from baseline to 5 years.

Fasting plasma glucose(mmol/l),

Time frame
baseline to 5 years
3

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)

Time frame
baseline to 5 years
4

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.

Time frame
baseline to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Third Military Medical University

Lead sponsor

Source ClinicalTrials.gov
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