THE EFFECT OF ACYL-GHRELIN ON SODIUM REABSORPTION VIA ENAC IN HEALTHY VOLUNTEERS

THE EFFECT OF ACYL-GHRELIN ON SODIUM REABSORPTION VIA ENAC IN HEALTHY VOLUNTEERS IN A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, CROSS-OVER STUDY

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002538-32-DK

Enrollment

Registered

2015-09-01

Start date

2015-10-26

Completion date

Unknown

Last updated

2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The physiological responses to Acyl-ghrelin-injection on the sodium reabsorption via ENaC in healthy subjects. MedDRA version: 20.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations

Interventions

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Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18-40 years, BMI 18,5-30kg/m2, women must use contraception. 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of Acyl-ghrelin on the sodium reabsorption via ENaC in a randomized, placebo-controlled, double-blind, cross-over study in healthy subjects, by measuring kidney functions, blood pressure and vasoactive hormones.;Secondary Objective: Not applicable;Primary end point(s): Fractional sodium excreation (FENa);Timepoint(s) of evaluation of this end point: When all subjects have completed and the blood and urine samples have been analyzed.	—

Measure

Time frame

Main Objective: To investigate the effect of Acyl-ghrelin on the sodium reabsorption via ENaC in a randomized, placebo-controlled, double-blind, cross-over study in healthy subjects, by measuring kidney functions, blood pressure and vasoactive hormones.;Secondary Objective: Not applicable;Primary end point(s): Fractional sodium excreation (FENa);Timepoint(s) of evaluation of this end point: When all subjects have completed and the blood and urine samples have been analyzed.

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Secondary

Measure	Time frame
Secondary end point(s): Augmentation index, brachial blood pressure, central blood pressure, heart rate, pulse wave velocity, free water clearance, potassium clearance, sodium clearance, fractional excretion of potassium, fractional excretion of sodium, glomerular filtration rate, plasma levels of acylghrelin, plasma levels of aldosterone, plasma levels of angiotensin II , plasma concentrations of vasopressin, plasma concentrations of atrial natriutisk peptide,plasma levels of brain natriuretic peptide, plasma levels of renin, plasma concentration of ghrelin and acyl-ghrelin, urinary excretion of aquaporin2, urinary excretion of ENaC (epithelial sodium channel), urinary concentration of NCC (sodium chloride co-transporter) and NKCC2 (natriumkalium2klorid co-transporter) and urine volume.;Timepoint(s) of evaluation of this end point: When all subjects have completed and the blood and urine samples have been analyzed.	—

Measure

Time frame

Secondary end point(s): Augmentation index, brachial blood pressure, central blood pressure, heart rate, pulse wave velocity, free water clearance, potassium clearance, sodium clearance, fractional excretion of potassium, fractional excretion of sodium, glomerular filtration rate, plasma levels of acylghrelin, plasma levels of aldosterone, plasma levels of angiotensin II , plasma concentrations of vasopressin, plasma concentrations of atrial natriutisk peptide,plasma levels of brain natriuretic peptide, plasma levels of renin, plasma concentration of ghrelin and acyl-ghrelin, urinary excretion of aquaporin2, urinary excretion of ENaC (epithelial sodium channel), urinary concentration of NCC (sodium chloride co-transporter) and NKCC2 (natriumkalium2klorid co-transporter) and urine volume.;Timepoint(s) of evaluation of this end point: When all subjects have completed and the blood and urine samples have been analyzed.

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Countries

Denmark

Contacts

Public ContactMy Emma Sofie Malmberg

Medicinsk Forskningsafsnit, Regionshospitalet Holstebro (Department of Medical Research, Regional Hospital Holstebro)

mymalmbe@rm.dk004578436588

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026