Oral Potassium Supplementation in Healthy Men - Interactions With the Renin-angiotensin-aldosterone System and the Sympathetic Nervous System
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Angiotensin II stimulated S-aldosterone
研究概览
简要总结
Project titel: Oral potassium supplementation in healthy men - interactions with the renin-angiotensin-aldosterone system and the sympathetic nervous system Protocol number: KARAASS-1 EudraCT number: 2013-004460-66
Introduction The global burden of hypertension is huge. This project focuses on the role of potassium in human blood pressure regulation. A potassium rich diet lowers blood pressure and some studies have shown an increase in blood pressure during potassium depletion. Thus an inverse correlation between potassium intake and blood pressure exists. In this trial the objective is to test how an oral potassium supplementation, administered in form of the drug Kaleorid®, interacts with the renin-angiotensin-aldosterone system and the sympathetic nervous system.
Methods This is a randomized clinical placebo-controlled double-blinded crossover trial. A group of healthy men will be randomized to either 4 weeks treatment with the drug Kaleorid®, 750mg, 3 tablets 3 times daily or to 4 weeks treatment with placebo.
On day 26 in the first treatment period the participants meet at the hospital to start a 24-hours ambulatory blood pressure and collect a 48-hours urine sample. The same day a blood sample, an electrocardiogram (ECG) and a fat biopsy from the gluteal region will be done. The fat biopsy is expected to contain resistance vessels, which are to be investigated further in the laboratory.
On day 28 in the first treatment period the participants meet at the hospital again and are tested with an intravenous Angiotensin II infusion followed by continuous measurement of blood pressure and the following aldosterone response (using blood samples). Blood pressure will be measured with Finger Plethysmography and vascular tonus will be evaluated with the use of Impedance Cardiography, Finger Plethysmography and Doppler Ultrasound measurements of blood flow before, during and after the Angiotensin II infusion.
After this first period of treatment and testing a "washout" period of two weeks is inserted. After "washout", the participants crossover and starts the second treatment period.
Feasibility All necessary authorities have approved the trial and all cooperation is established.
详细描述
Project titel: Oral potassium supplementation in healthy men - interactions with the renin-angiotensin-aldosterone system and the sympathetic nervous system Protocol number: KARAASS-1 EudraCT number: 2013-004460-66
Objective
The objective of the study is to investigate how an oral potassium supplementation, administrated in form of the drug Kaleorid® regulates the human blood pressure. More specific the objective is to test how an oral potassium supplementation interacts with:
- The renin-angiotensin-aldosterone system and
- The sympathetic nervous system
To do this we plan to conduct a randomized clinical placebo-controlled double-blinded crossover trial to test how the drug Kaleorid® affects components in the renin-angiotensin-aldosterone system and the sympathetic nervous system compared with placebo in healthy men.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age: 20-55
- •Office Blood Pressure: < 140/90 mmHg
- •BMI: 18,5-30,0 kg/m2
- •Signed consent form
排除标准
- •Diabetes mellitus
- •Cerebrovascular disease, ischemic heart disease, peripheral artery disease
- •Kidney disease
- •Adrenal disease
- •Medical treatment
- •Drug or alcohol abuse
- •Pathological ECG
- •Mental not suitable
- •Hyperkalemia
研究组 & 干预措施
Kaleorid
4 weeks treatment with Kaleorid, 750mg, 3 tablets 3 times daily.
干预措施: Kaleorid, 750mg (trade name), Potassium chloride (active substance) (Drug)
Placebo
4 weeks treatment with Placebo tablets, 3 tablets 3 times daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Angiotensin II stimulated S-aldosterone
时间窗: Day 28 in each treatment period up to 70 days from start in the study
次要结局
- Change in Angiotensin II stimulated blood pressure(Day 28 in each treatment period up to 70 days from start in the study)
- Level of receptor function in resistance vessels from fat biopsies(Day 26 in each treatment period up to 70 days from start in the study)
- Change in Angiotensin II stimulated total peripheral resistance (TPR)(Day 28 in each treatment period up to 70 days from start in the study)
- Change in Angiotensin II stimulated resistance index (RI) in central vessels of the abdomen(Day 28 in each treatment period up to 70 days from start in the study)
- Urinary content of epinephrine(Day 26 in each treatment period up to 70 days from start in the study)
- Urinary content of norepinephrine(Day 26 in each treatment period up to 70 days from start in the study)
- Change in Angiotensin II stimulated P-epinephrine(Day 28 in each treatment period up to 70 days from start in the study)
- Change in Angiotensin II stimulated P-norepinephrine(Day 28 in each treatment period up to 70 days from start in the study)
- Level of receptor expression in resistance vessels from fat biopsies(Day 26 in each treatment period up to 70 days from start in the study)
- P-epinephrine(Day 26 in each treatment period up to 70 days from start in the study)
- P-norepinephrine(Day 26 in each treatment period up to 70 days from start in the study)
研究者
Rasmus Dreier
Medical Doctor
Glostrup University Hospital, Copenhagen