Profiling Extracellular Vesicle Cargo in Obesity and Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Identify circulating EV-derived protein and RNA signatures associated with T2D
研究概览
简要总结
The purpose of this research is to obtain blood samples before and after a bariatric procedure to better understand the reasons for glucose intolerance and insulin resistance (diabetes) in the obesity, and the reasons for improvement of diabetes after bariatric surgery
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in the Bariatric Surgery Program.
- •Patients with A1c of 6.5 or higher within the last 6 months. OR
- •Patients with A1c less than 6.5; have diagnosis of stable type 2 diabetes for > 6 months.
排除标准
- •Disqualified for Bariatric Surgery.
- •BMI < 35 kg/m^2.
结局指标
主要结局
Identify circulating EV-derived protein and RNA signatures associated with T2D
时间窗: 1 year
Circulating EVs will be isolated from plasma samples from patients with extreme obesity, with either T2D or normoglycemia. EV-derived proteins will be analyzed by shotgun proteomics using mass spectrometry and RNA by sequencing or microarray RNA technology to identify differential abundance between T2D and normoglycemia.
Identify changes in circulating EV cargo in patients whose T2D resolves after sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB) or duodenal switch procedures.
时间窗: 1 year
Plasma samples will be prospectively obtained from patients recruited in Aim 1 at baseline and within four weeks and at one-year after SG, RYGB or Duodenal Switch Procedures. EVs will be isolated, and protein and RNA profiled as described in Aim 1. Changes in EV cargo from baseline to one-year post-SG or RYGB and T2D remission will be assessed.
次要结局
未报告次要终点
研究者
Michael A. Edwards
Principal Investigator
Mayo Clinic