Cardiovascular Outcomes in Patients With Type 2 Diabetes and Obesity: Comparison of Metabolic Surgery Versus Usual Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91,700
- 试验地点
- 1
- 主要终点
- All-Cause Mortality and/or Cardiovascular Outcomes
研究概览
简要总结
The objective of the analysis was to evaluate the relationship between bariatric surgery and cardiovascular outcomes in obese patients with type 2 diabetes.
详细描述
The objective of the analysis was to evaluate the relationship between bariatric surgery and cardiovascular outcomes in obese patients with type 2 diabetes. This is a retrospective matched cohort study of patients with diabetes that underwent bariatric surgery at the Cleveland Clinic between 2004-2017. Each bariatric patient was matched to a non-surgical control with obesity and type 2 diabetes in a 1:5 ratio using data from the Electronic Medical Record (EMR). The maximum observation time was 10 years. Cumulative incidence rates for all-cause mortality and cardiovascular events were calculated at years 1, 3, 5, 7 and 10. Kaplan-Meier curves were created for all the outcomes with all-cause mortality considered as a completing risk.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type II diabetes
- •18-80 years old
- •HBA1c >6.4 OR taking at lease one (1) diabetes medication (insulin or non-insulin)
排除标准
- •History of liver, heart, or lung transplant
- •Emergency department admission within 5 days prior
- •Cancer diagnosis within 1 year prior
- •Any prior ejection fraction <20%
- •Non-surgical controls were excluded if they died within 30 days after the index date (date of surgery for the bariatric patients)
- •Last follow-up date on or before the index date
研究组 & 干预措施
Non-Surgical Control
Matched non-surgical controls with type 2 diabetes and BMI >=30
Bariatric Surgery
Patients with type 2 diabetes with BMI >=30 that underwent bariatric surgery
干预措施: Bariatric Surgery (Procedure)
结局指标
主要结局
All-Cause Mortality and/or Cardiovascular Outcomes
时间窗: From index date through a maximum of 8 years
First occurrence of all-cause mortality, coronary artery disease event, stroke, heart failure, nephropathy, or atrial fibrillation
次要结局
- Major Adverse Cardiovascular Event (MACE-3)(From index date through a maximum of 8 years)
- All-Cause Mortality(From index date through a maximum of 8 years)
- Coronary Disease Events(From index date through a maximum of 8 years)
- Cerebrovascular Events(From index date through a maximum of 8 years)
- Heart Failure(From index date through a maximum of 8 years)
- Development of Nephropathy(From index date through a maximum of 8 years)
- Atrial Fibrillation(From index date through a maximum of 8 years)
研究者
Ali Aminian
Principal Investigator
The Cleveland Clinic