Oral potassium supplementation in healthy men - interactions with the renin-angiotensin-aldosterone system and the sympathetic nervous system

Phase 1

Conditions: Blood pressure regulation and hypertension
MedDRA version: 16.1Level: LLTClassification code 10008393Term: Change in blood pressureSystem Organ Class: 100000004866
MedDRA version: 16.1Level: LLTClassification code 10053967Term: Potassium supplementationSystem Organ Class: 100000004865
Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

Registration Number: EUCTR2013-004460-66-DK

Lead Sponsor: Jørgen Jeppesen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 25

Inclusion Criteria

Male
Age: 20-55
Office Blood pressure: < 140/90 mmHg
BMI: 18,5-30,0 kg/m2
Signed consent form

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Diabetes mellitus
Cerebrovascular disease, ischemic heart disease, peripheral artery disease
Kidney disease
Adrenal disease
Ulcers
Medical treatment
Drug or alcohol abuse
Pathological ECG
Mental not suitable
Hyperkalemia

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the trial is to test whether oral potassium supplementation, administered as Kaleorid, interacts with the renin-angiotensin-aldosterone system and the sympathetic nervous system.<br>;Secondary Objective: Not applicable;Primary end point(s): Angiotensin II stimulated S-aldosterone;Timepoint(s) of evaluation of this end point: Date: 2017-10-01

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Date: 2017-10-01;Secondary end point(s): Angiotensin II stimulated blood pressure<br>Angiotensin II stimulated total peripheral resistance (TPR)<br>Angiotensin II stimulated resistance index (RI) in central vessels of the abdomen<br>Level of receptor expression and receptor function in resistance vessels from fat biopsies<br><br>P-epinephrine and P-norepinephrine<br>Urinary content of epinephrine and norepinephrine<br>Angiotensin II stimulated P-epinephrine and Angiotensin II stimulated P-norepinephrine