An observational study in Metabolic Syndrome, sponsored by Third Military Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by Third Military Medical University · Observational
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.
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
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.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 458 observational studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Third Military Medical University is the lead sponsor of 81 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients underwent bariatric surgery or medical therapy for metabolic syndrome between 2010 and 2020 at our institution.
BMI\<35 kg/m\^2
Patients who failed to follow up
The group of bariatric surgery therapy in metabolic syndrome patients.
Procedure: Bariatric surgery
The group of medical therapy in metabolic syndrome patients
Drug: Hypoglycemic drugs
drug
Also known as: antihypertensive drugs, lipid-lowering drugs
surgery
Also known as: metabolic surgery
Change in metabolic parameters from baseline to 5 years.
Waist circumference(cm)
Time frame: baseline to 5 years
Change in metabolic parameters from baseline to 5 years.
body mass index(kg/m\^2)
Time frame: baseline to 5 years
Change in glycosylated hemoglobin from baseline to 5 years.
glycosylated hemoglobin(%)
Time frame: baseline to 5 years
Change in plasma glucose from baseline to 5 years.
Fasting plasma glucose(mmol/l),
Time frame: 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)
Time frame: 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.
Time frame: baseline to 5 years
Hypoglycemic drugs use
The number and daily drug dose of hypoglycemic drugs
Time frame: baseline to 5 years
Antihypertensive drugs use
The number and daily drug dose of antihypertensive drugs
Time frame: baseline to 5 years
Lipid-lowering drugs use
The number and daily drug dose of lipid-lowering drugs
Time frame: baseline to 5 years
Plan to share: No
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Third Military Medical University