Effect of Bariatric Surgery Versus Medical Therapy on Metabolic Syndrome

Study Overview
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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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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.

Official Title
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Army Medical University

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Drug: Hypoglycemic drugs
* Procedure: Bariatric surgery


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BS group<br>The group of bariatric surgery therapy in metabolic syndrome patients. | Procedure: Bariatric surgery<br>* surgery<br>* Other names: metabolic surgery;|
| MT group<br>The group of medical therapy in metabolic syndrome patients | Drug: Hypoglycemic drugs<br>* drug<br>* Other names: lipid-lowering drugs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in metabolic parameters from baseline to 5 years. | Waist circumference(cm) | baseline to 5 years | 
| Change in metabolic parameters from 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. | glycosylated hemoglobin(%) | baseline to 5 years | 
| Change in plasma glucose from baseline to 5 years. | Fasting plasma glucose(mmol/l), | 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) | 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. | baseline to 5 years | 
| Hypoglycemic drugs use | The number and daily drug dose of hypoglycemic drugs | baseline to 5 years | 
| Antihypertensive drugs use | The number and daily drug dose of antihypertensive drugs | baseline to 5 years | 
| Lipid-lowering drugs use | The number and daily drug dose of lipid-lowering drugs | baseline to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic syndrome, Medical therapy, Bariatric surgery, body mass index