Effect of Bariatric Surgery Versus Medical Therapy on Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— EBSMTMS  

Official title:

Army Medical University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05363059
• Other study ID #: EBSMTMS
• Status: Recruiting
• Start date: May 1, 2010
• Est. completion date: May 30, 2022

Study information

• Verified date: May 2022
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Drug:
• Hypoglycemic drugs
drug

Procedure:
• Bariatric surgery
surgery

Locations

Country	Name	City	State
China	Stryker Laparoscopy	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in metabolic parameters from baseline to 5 years.	Waist circumference(cm)	baseline to 5 years
Primary	Change in metabolic parameters from baseline to 5 years.	body mass index(kg/m^2)	baseline to 5 years
Secondary	Change in glycosylated hemoglobin from baseline to 5 years.	glycosylated hemoglobin(%)	baseline to 5 years
Secondary	Change in plasma glucose from baseline to 5 years.	Fasting plasma glucose(mmol/l),	baseline to 5 years
Secondary	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
Secondary	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
Secondary	Hypoglycemic drugs use	The number and daily drug dose of hypoglycemic drugs	baseline to 5 years
Secondary	Antihypertensive drugs use	The number and daily drug dose of antihypertensive drugs	baseline to 5 years
Secondary	Lipid-lowering drugs use	The number and daily drug dose of lipid-lowering drugs	baseline to 5 years