Army Medical University
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in metabolic parameters from baseline to 5 years.
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Patients who failed to follow up
- •Insulin dependent diabetes
- •congenital dementia
- •brain trauma
- •severe hypoglycemic coma
- •cerebrovascular disease
- •heart disease
- •renal dysfunction
- •alcohol abuse
- •mental illness
- •psychoactive substance abuse
- •unwillingness to provide informed consent
研究组 & 干预措施
BS group
The group of bariatric surgery therapy in metabolic syndrome patients.
干预措施: Bariatric surgery (Procedure)
MT group
The group of medical therapy in metabolic syndrome patients
干预措施: Hypoglycemic drugs (Drug)
结局指标
主要结局
Change in metabolic parameters from baseline to 5 years.
时间窗: baseline to 5 years
body mass index(kg/m\^2)
次要结局
- Changes of CVD risk(baseline to 5 years)
- Lipid-lowering drugs use(baseline to 5 years)
- Antihypertensive drugs use(baseline to 5 years)
- Change in glycosylated hemoglobin from baseline to 5 years.(baseline to 5 years)
- Change in plasma glucose from baseline to 5 years.(baseline to 5 years)
- Change in blood lipids from baseline to 5 years.(baseline to 5 years)
- Hypoglycemic drugs use(baseline to 5 years)
研究者
Zhiming Zhu
Director, Center for Hypertension and Metabolic Diseases, Department of Hypertension and Endocrinology, Daping Hospital
Third Military Medical University