Overview

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

Status:
Unknown status
Trial end date:
2018-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Erling Bjerregaard Pedersen
Collaborator:
University of Aarhus
Criteria
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.