Global Randomized Prospective Study of Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- HbA1c < 7.0%
研究概览
简要总结
The present study is the first stage of a research program whose ultimate goal is to conduct a randomized clinical trial involving type 2 diabetics with BMI from 30.0 to 39.9 kg/m2. This program will determine the relative effectiveness of RYGB combined with intensive medical management (IMM), versus IMM alone, in reducing CVD event rates and mortality in patients with poorly controlled diabetes. IMM will include rigorous lifestyle modification for weight loss and stepped pharmacologic treatment for diabetes and other CVD risk factors. The proposed study is a randomized trial which will provide an assessment of the efficacy of treatment, in reducing CVD risk factors and also assessing the feasibility, cost, and safety of a larger trial.
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
- 30 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30 to 67 years at eligibility visit.
- •Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, and HbA1c ≥ 8.0 %.
- •Body Mass Index (BMI) ≥ 30.0 kg/m2 and ≤ 39.9 kg/m2 at eligibility visit.
- •Willingness to accept random assignment to either treatment group.
- •Expect to live or work within approximately one hour's traveling time from the study clinic for the duration of the two-year trial.
- •Willingness to comply with the follow-up protocol and successful completion of the run-in (described below).
- •Written informed consent.
排除标准
- •Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
- •Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
- •Cardiac stress test indicating that surgery or IMM would not be safe.
- •Pulmonary embolus or thrombophlebitis in the past six months.
- •Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.
- •Significant anemia (hemoglobin 1.0 g or more below normal range) or history of coagulopathy.
- •Serum creatinine ≥ 1.5 mg/dl.
- •HbA1c > 14.0%.
研究组 & 干预措施
1
intensive medical management
干预措施: intensive medical management (Other)
2
Roux-en-Y gastric bypass with intensive medical management
干预措施: RYGB & IMM (Other)
结局指标
主要结局
HbA1c < 7.0%
时间窗: 12 Months
LDL cholesterol < 100 mg/dl
时间窗: 12 Months
Systolic blood pressure < 130 mm Hg
时间窗: 12 Months
次要结局
未报告次要终点