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The Effect of Acyl-Ghrelin on Kidney Function and Blood Pressure in Healthy Volunteers

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02528422
Acronym
DOAG
Enrollment
15
Registered
2015-08-19
Start date
2015-05-31
Completion date
2018-01-31
Last updated
2015-08-19

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

Conditions

Renal Tubular Transport

Brief summary

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.

Interventions

DRUGAcyl-Ghrelin

Sponsors

University of Aarhus
CollaboratorOTHER
Erling Bjerregaard Pedersen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18-40 years, * BMI 18,5-30kg/m2, * women must use contraception.

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

MeasureTime frameDescription
Fractional sodium excreation (FENa)5-6 HoursMeasurement of FENa at baseline and after Acyl-Ghrelin injection

Secondary

MeasureTime frameDescription
Renal function5-6 HoursMeasurement of GFR, FEK and CH20 at baseline and after Acyl-Ghrelin injection
Water and sodium transport5-6 HoursMeasurement of u-AQP2, u-NCC , u-NKCC -2 and u-ENaC at baseline and after Acyl-Ghrelin
Vasoactive hormones5-6 HoursMeasurement of p-BNP , PRC, p-AngII , p-Aldo and p-AVP at baseline and after Acyl-Ghrelin
Blood pressure5-6 HoursMeasurement of Central blood pressure, PWV, AIx and Peripheral blood pressure at baseline and after Acyl-Ghrelin

Countries

Denmark

Contacts

Primary ContactMy ES Malmberg
mymalmbe@rm.dk+4578436588

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026