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临床试验/NCT04167761
NCT04167761已完成1 期

Ertugliflozin: Cardioprotective Effects on Epicardial Fat

Stanford University2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
61
试验地点
2
主要终点
Rate of isoproterenol-stimulated lipolysis to measure metabolic flexibility in epicardial adipose tissue samples.

研究概览

简要总结

The purpose of this study is to learn if Sodium-Glucose Cotransporter 2 inhibitor (SGLT2i) medications enhance beneficial properties of epicardial adipose tissue including metabolic flexibility, insulin sensitivity, decreased cell size and reduced inflammation.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient at Stanford Cardiovascular Surgery clinic who is scheduled for cardiac bypass surgery or vascular surgery
  • history of Diabetes Mellitus Type 2 currently diet controlled, or on metformin or dpp4 inhibitors

排除标准

  • allergy or intolerance to interventional medication
  • currently taking insulin, glp-1 inhibitors, or sulfonylureas

研究组 & 干预措施

Ertugliflozin (treated tissue)

Experimental

Adipose tissue samples collected from participants were treated with Ertugliflozin at a concentration of 25 µM in vitro. Tissue samples were incubated with Ertugliflozin to evaluate its effects on lipolysis, inflammation, and gene expression in epicardial, pericardial, and subcutaneous adipose tissues

干预措施: Ertugliflozin (Drug)

结局指标

主要结局

Rate of isoproterenol-stimulated lipolysis to measure metabolic flexibility in epicardial adipose tissue samples.

时间窗: Time to collect tissue collected during surgery (up to 15 minutes)

Analysis will be performed using Lipolysis Colorimetric Assay and measured by glycerol content on standard curve. Indirect effects of SGLT2i in vivo in epicardial adipose tissue will be compared to Glipizide by measuring rate of lipolysis, or breakdown of adipose in to free fatty acids.

次要结局

  • Average insulin mediated glucose uptake (IMGU) to measure insulin sensitivity in epicardial adipose tissue samples.(Time to collect tissue collected during surgery (up to 15 minutes))
  • Characterization of the inflammatory cytokine expression profile in epicardial adipose tissue samples.(Time to collect tissue collected during surgery (up to 15 minutes))
  • Distribution of adipose cell size in epicardial tissue.(Time to collect tissue collected during surgery (up to 15 minutes))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tracey McLaughlin

Professor of Medicine

Stanford University

研究点 (2)

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