NCT06355219已完成不适用
Macrovascular and Microvascular Outcomes in Patients With Type 2 Diabetes and Obesity: Comparison of Metabolic Surgery Versus GLP-1 Receptor Agonists
Ali Aminian0 个研究点目标入组 3,932 人开始时间: 2010年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,932
- 主要终点
- All-cause Mortality Rate
研究概览
简要总结
The goal of this study is to compare the impact of metabolic surgery and a class of anti-diabetes medications (Glucagon-like peptide-1 receptor agonists,GLP-1 RAs) on occurrence of diseases involving small and large vessels such as heart disease, kidney disease, and disease of the retina (a part of the eye), as well as deaths.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI>=30 kg/m^2
- •Type 2 Diabetes Mellitus
- •18-75 y/o
- •Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) (Surgical Cohort) at CCHS hospitals in Florida and Ohio between January 1, 2010, and December 31, 2017
- •For the GLP-1RA Group:
- •Follow-up of at least 30 days after the assigned index date
- •Did not meet any of the exclusion criteria for surgical patients (see below)
- •Did not have metabolic surgery prior to assigned index date.
- •Continuously received GLP-1 RA for ≥2 years (prescription order for GLP-1 RA placed between January 1, 2010, and December 31, 2017, as well as ≥ 3 documented prescription fills within 1 year before their assigned index date and ≥ 3 fills within 1 year after their index date)
排除标准
- •History of solid organ transplant
- •Cardiac ejection fraction <20% any time before index date
- •Active cancer
- •Cancer code within 1 year before index date
- •ED admission within 5 days before index date
- •Dialysis or estimated glomerular filtration rate (eGFR) <20 before index date.
- •Received care in CCHS locations other than in Ohio and Florida.
结局指标
主要结局
All-cause Mortality Rate
时间窗: After surgical or assigned index date to Dec 31, 2022
Death from all causes percentage
次要结局
- Incidence of MACE(After surgical or assigned index date to Dec 31, 2022)
- Incidence of Retinopathy(After surgical or assigned index date to Dec 31, 2022)
- Incidence of Nephropathy(After surgical or assigned index date to Dec 31, 2022)
研究者
Ali Aminian
Director of the Bariatric and Metabolic Institute
The Cleveland Clinic
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