Acute Effects of GLP-1 on Renal Hemodynamics: Simultaneous Perfusion and Oxygenation Measurements in Cortex and Medulla Using Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Arterial Spin Labeled (ASL)
研究概览
简要总结
This study investigates the hypothesis, that GLP-1's suppression of ANG II and natriuretic action increase medullary perfusion and decrease oxygen consumption, leading to higher tissue oxygenation.
详细描述
Human studies have recently demonstrated a significant natriuretic effect of GLP-1 when the extracellular fluid volume (ECFV) is expanded by intravenous sodium-loading; in these studies, there was a suppression of ANG II with no change in net renal hemodynamics, pointing to a tubular mechanism for reduced NaCl reabsorption secondary to the ANG II suppression. In the current randomized and controlled study, investigators aim to test the hypothesis that GLP-1's suppression of ANG II and natriuretic action increase medullary perfusion and decrease oxygen consumption, leading to higher tissue oxygenation. Thus, contributing to the renoprotective action of GLP-1.
Under fixed sodium intake for 4 days before each study day, 10 healthy male participants will be investigated during a 1-hour infusion of GLP-1 (1.5 pmol/kg/min) or vehicle together with an intravenous infusion of 0.9% NaCl. Interleaved measurements of RAF, oxygenation (T2*) and perfusion by arterial spin labeling in the renal cortex and medulla at fixed time points will be conducted, using Magnetic Resonance Imaging (MRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Normal health demonstrated by medical examination.
- •Normal values for fasting plasma glucose, total cholesterol, triglyceride, HDL, LDL, creatinine, AST, ALT and electrolyte concentrations.
排除标准
- •Immunosuppressive treatment for the previous 12 months.
- •Alcohol abuse.
- •Medical treatment with oral glucocorticoids, dipeptidyl peptidase-4 (DPP-4) inhibitors, or GLP-1 receptor agonists that, in the opinion of the investigator, may interfere with glucose metabolism.
- •Use of lithium.
- •Medical treatment that affects insulin secretion or cardiovascular efficacy goals.
- •Liver disease (ALT> 2 x normal value).
- •Renal impairment (creatinine> 130 µM and / or albuminuria).
- •Severe claustrophobia.
- •MRI incompatible foreign bodies.
研究组 & 干预措施
human glucagon-like peptide-1
Intervention:
Drug: human glucagon-like peptide-1 Other names: GLP-1
干预措施: Glucagon-Like Peptide 1 (Drug)
Placebo
Intervention:
Drug: Placebo (saline) Other names: Placebo for human glucagon-like peptide-1
干预措施: saline 0.9% (Drug)
结局指标
主要结局
Arterial Spin Labeled (ASL)
时间窗: 1 hour
Changes in Arterial Spin Labeled (ASL) MRI Perfusion Imaging in renal cortex and medulla
T2* signal
时间窗: 1 hour
Changes in T2\* signal in renal cortex and medulla
Renal Artery Flow Phase (RAF)
时间窗: 1 hour
Changes in Renal Artery Flow Phase (RAF)-Contrast Magnetic Resonance
次要结局
未报告次要终点
研究者
Ali Asmar
MD, PhD
Rigshospitalet, Denmark