STAMPEDE: Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.
研究概览
简要总结
The aim of the study is to compare the relative clinical outcomes between advanced medical therapy alone or advanced medical therapy combined with bariatric surgery [either Roux-en-Y gastric bypass (RYGBP) or laparoscopic sleeve gastrectomy] in patients with type 2 diabetes and a body mass index (BMI) between 27 and 43 kg/m2. The study will examine the short and long term effects of each intervention on biochemical resolution of diabetes, diabetic complications, and end-organ damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus with HbA1c > 7.0%
- •Body mass index > 27 and < 43 kg/m2
- •Candidate for general anesthesia
排除标准
- •Prior bariatric surgery of any kind
- •Cardiovascular conditions including significant coronary artery disease, peripheral vascular disease, uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension
- •Kidney disease or chronic renal insufficiency with a creatinine level > 1.8 mg/dl
- •Known history of chronic liver disease (except for NAFLD/NASH)
- •Gastrointestinal disorders, malabsorptive disorders, or inflammatory bowel disease
- •Psychiatric disorders including dementia, active psychosis, severe depression requiring > 2 medications, history of suicide attempts, alcohol or drug abuse within the previous 12 months
- •Severe pulmonary disease defined as FEV1 < 50% of predicted value
- •Pregnancy
研究组 & 干预措施
Medical therapy
Intensive medical therapy for diabetes
Gastric Bypass
Procedure/Surgery: Bariatric surgery laparoscipic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
干预措施: Gastric bypass (Procedure)
Sleeve Gastrectomy
Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
干预措施: Sleeve Gastrectomy (Procedure)
结局指标
主要结局
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.
时间窗: 1 year
The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure).
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications
时间窗: 1 year
The proportion of subjects with a glycated hemoglobin level of 6% or less(without diabetes medications) 12 months after randomization.
次要结局
- Diabetes Medication - Use of Insulin(1 year)
- Diabetes Medication - Use of Biguanides(1 year)
- Cardiovascular Medications - Beta Blocker(1 year)
- Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)(1 year)
- Cardiovascular Medications - Anticoagulants(1 year)
- Diabetes Medication - Use of Thiazolidinedione(1 year)
- Diabetes Medication - Use of Incretin Mimetics(1 year)
- Diabetes Medication - Use of Secretagogue(1 year)
- Cardiovascular Medications - Lipid Lowering Agents(1 year)
- Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).(1, 2, and 5 years)
- Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations.(1, 2, and 5 years)
- The Cost-effectiveness of Each Program and the Side Effects and /or Complications.(1, 2, and 5 years.)
- Change in Glycated Hemoglobin (HbA1c)(1 year - baseline)
- Fasting Plasma Glucose(1 year)
- Glycated Hemoglobin (HbA1c)(1 year)
- Body Weight(1 year)
- Change in Body Weight From Baseline(1 year)
- Body Mass Index (BMI)(1 year)
- Change in Body Mass Index (BMI)(1 year)
- Change in Systolic Blood Pressure (SBP)(1 year)
- Change in High-density Lipoprotein (HDL)(1 year)
- Change in Triglycerides(1 year)
- Change in High-sensitivity C-reactive Protein (Hs-CRP)(1 year)