The Effect of Acyl-Ghrelin on Kidney Function and Blood Pressure in Healthy Volunteers - A Randomized, Cross-over, Single-blind, Placebo-controlled Dose-response Study of the Acyl-ghrelin Induced Effects on GFR, Tubular Transport of Sodium and Water in Different Nephron Segments and Central and Peripheral Blood Pressure
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Fractional sodium excreation (FENa)
研究概览
简要总结
Ghrelin (growth hormone release inducer) is produced in the stomach. The active form of Ghrelin is Acyl-Ghrelin. Acyl-Ghrelin stimulates the Ghrelin receptors. Ghrelin receptors are detected in the distal tubules in mice and animal studies have shown that Ghrelin increases the absorption of sodium in the renal tubules. Ghrelin infusion directly into the renal artery of rats increased sodium reabsorption in the distal nephron, presumably via the epithelial sodium channels (ENaC).
The purpose of the study is to measure the acyl-ghrelin induced effects on GFR, tubular transport of sodium and water in different nephron segments and central and peripheral blood pressure in a randomized, cross-over, single-blind, placebo-controlled dose-response study.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-40 years,
- •BMI 18,5-30kg/m2,
- •women must use contraception.
排除标准
- •Tobacco smoking,
- •substance abuse,
- •consumption of more than 7 units of alcohol/week for women and more than 14 units/week for men,
- •medical treatment except for contraception,
- •pregnancy or nursing,
- •allergy to acyl-ghrelin,
- •significant clinical signs of heart-, lung-, liver-, kidney-, endocrine-, brain- or neoplastic disorders,
- •clinically significant abnormal findings in screening blood samples,
- •urine sample or ECG,
- •office blood pressure over 140/90 mmHg,
- •donation of blood within 1 month of the first day of investigation.
研究组 & 干预措施
50 µg Acyl-Ghrelin
Intravenous injection on examination day.
干预措施: Acyl-Ghrelin (Drug)
100 µg Acyl-Ghrelin
Intravenous injection on examination day.
干预措施: Acyl-Ghrelin (Drug)
Isotonic Sodium Chloride
Intravenous injection on examination day.
干预措施: Acyl-Ghrelin (Drug)
结局指标
主要结局
Fractional sodium excreation (FENa)
时间窗: 5-6 Hours
Measurement of FENa at baseline and after Acyl-Ghrelin injection
次要结局
- Renal function(5-6 Hours)
- Water and sodium transport(5-6 Hours)
- Vasoactive hormones(5-6 Hours)
- Blood pressure(5-6 Hours)
研究者
Erling Bjerregaard Pedersen
Professor, MD, Dr.Sci.
Regional Hospital Holstebro