The Effect of SGLT2 Inhibition on Adipose Tissue Inflammation and Endothelial Function Pilot
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 3 Months
研究概览
简要总结
Obesity is associated with increased cardiometabolic disease risk due, in part, to heightened chronic inflammation arising from adipose tissue. There are no current targeted therapies to prevent or reverse the chronic inflammation of obesity, and a better understanding of these inflammatory pathways in humans is key to future therapeutic interventions. This project will determine both the anti-inflammatory potential of the SGLT2 inhibitor empagliflozin, and the contribution of adipose inflammation to surrogate measures of cardiovascular disease in a randomized controlled trial of obese patients.
详细描述
This study will be expanded to include another 10 participants. Enrollment will begin July 1, 2023.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Empagliflozin
Individuals receive empagliflozin 25mg/day orally for 12 weeks
干预措施: Empagliflozin 25 MG (Drug)
结局指标
主要结局
Change in Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 3 Months
时间窗: Baseline to 12 weeks
Pro-inflammatory T helper type 1 cells are quantified using flow cytometry
Change in Flow-mediated Dilation After 3 Months
时间窗: Baseline to 12 weeks
Endothelial function quantified using flow-mediated dilation by ultrasound, measuring percentage increase in artery diameter during hyperemia.
Change in Liver Steatosis at 3 Months
时间窗: Baseline to 12 weeks
Liver steatosis assessment by transient elastography-controlled attenuation parameter imaging, reported as Controlled Attenuation Parameter (CAP)
次要结局
- Change in the Plasma Inflammatory Cytokine IL-6 After 3 Months(Baseline to 12 weeks)
- Change in Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 2 Weeks(Baseline to 2 weeks)
研究者
Mona Mashayekhi
Clinical Instructor
Vanderbilt University Medical Center