Prospective Randomized Controlled Trial on the Effect of BAriatric Surgery Versus Optimal Medical Therapy on Cardiovascular Health and Progression of Atherosclerosis in Obese, Type II Diabetic Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 58
- 主要终点
- Subclinical Atherosclerosis (ecographic assessment of carotid artery intima-media thickness)
研究概览
简要总结
To assess the impact of weight loss due to bariatric surgery, as compared to the effect of optimal medical therapy alone on endothelial function, subclinical atherosclerosis, cardiovascular autonomic function in obese patient affected by type 2 diabetes.The study consists in a 2-arm randomized trial, in which patients will be randomly assigned to bariatric surgery or optimal medical therapy. Each patient will be studied at baseline (T0) and 12 months thereafter (T1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes: the American Diabetes Association (ADA) recommends the following criteria for diagnosis of diabetes: HbA1c ≥6.5% OR fasting plasma glucose‡ ≥126 mg/dL (7.0 mmol/L) OR 2-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test; 75-g glucose load should be used OR random plasma glucose concentration ≥200 mg/dL (11.1 mmol/L) in persons with symptoms of hyperglycemia or hyperglycemic crisis;
- •indication to bariatric surgery: BMI ≥35 kg/m2 and one or more obesity related co-morbidities, including Type 2 Diabetes Mellitus.
排除标准
- •overt cardiovascular disease (as assessed by clinical evaluation, physical examination, 12-lead ECG, 2D-echocardiogram);
- •smoking habit;
- •associated medical conditions, as chronic kidney disease (defined as creatinine clearance <60 mL/min/L.73m2), liver cirrhosis, malignancies, chronic congestive heart failure, acute or chronic inflammatory disease;
- •specific contraindication to bariatric surgery;
- •pregnancy;
- •medical conditions requiring acute hospitalization;
- •psychological conditions which may hamper patient's cooperation;
- •geographic inaccessibility.
研究组 & 干预措施
Bariatric Surgery
Gastric bypass
干预措施: Gastric bypass (Procedure)
Optimal Medical Therapy
planned visits, optimized hypoglycemic treatment, diet and lifestyle modification
干预措施: Medical therapy (Behavioral)
结局指标
主要结局
Subclinical Atherosclerosis (ecographic assessment of carotid artery intima-media thickness)
时间窗: 12 months
ecographic assessment of carotid artery intima-media thickness
Endothelial Function (ecographic assessment of flow-mediated dilation and nitrate mediated dilation)
时间窗: 12 months
ecographic assessment of flow-mediated dilation and nitrate mediated dilation
Cardiac autonomic function (heart rate variability measurements on 24-hour Holter ECG recordings)
时间窗: 12 months
heart rate variability measurements on 24-hour Holter ECG recordings
次要结局
未报告次要终点
研究者
Geltrude Mingrone
Associate Professor
Catholic University of the Sacred Heart