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

NCT02528422 — Phase 1, Unknown, 15 participants, Erling Bjerregaard Pedersen

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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

Registry	NCT02528422, acronym DOAG
Status	Unknown
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: single, basic science
Enrollment	15 (Estimated)
Sponsor	Erling Bjerregaard Pedersen (Other); collaborators: University of Aarhus
Conditions	Renal Tubular Transport
Interventions	Acyl-Ghrelin (Drug)
Dates	start 2015-05-01, primary completion 2018-01-01 (estimated), completion 2018-01-01 (estimated), first posted 2015-08-19, last updated 2015-08-19
Locations	1 site in Denmark

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
50 µg Acyl-Ghrelin	Active comparator	Drug: Acyl-Ghrelin	Intravenous injection on examination day.
100 µg Acyl-Ghrelin	Active comparator	Drug: Acyl-Ghrelin	Intravenous injection on examination day.
Isotonic Sodium Chloride	Placebo comparator	Drug: Acyl-Ghrelin	Intravenous injection on examination day.

Acyl-Ghrelin (Drug)

+Outcome measures

Primary outcomes

Fractional sodium excreation (FENa) [5-6 Hours]: Measurement of FENa at baseline and after Acyl-Ghrelin injection

Secondary outcomes

Renal function [5-6 Hours]: Measurement of GFR, FEK and CH20 at baseline and after Acyl-Ghrelin injection
Water and sodium transport [5-6 Hours]: Measurement of u-AQP2, u-NCC , u-NKCC -2 and u-ENaC at baseline and after Acyl-Ghrelin
Vasoactive hormones [5-6 Hours]: Measurement of p-BNP , PRC, p-AngII , p-Aldo and p-AVP at baseline and after Acyl-Ghrelin
Blood pressure [5-6 Hours]: Measurement of Central blood pressure, PWV, AIx and Peripheral blood pressure at baseline and after Acyl-Ghrelin

+Eligibility

Sex: All, ages: 18 Years to 40 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Department of Medical Research, Regional Hospital Holstebro	Holstebro	Denmark	Recruiting

+Investigators

Erling B Pedersen, Study chair, Department of Medical Research and Medicine, Holstebro Regional Hospital

+Funding

NIH grants: 2014

My Notes

Public

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