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

Erling Bjerregaard Pedersen15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Renal Tubular Transport

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Fractional sodium excreation (FENa)

Measurement of FENa at baseline and after Acyl-Ghrelin injection

Time frame: 5-6 Hours

Secondary Outcomes

Renal function

Measurement of GFR, FEK and CH20 at baseline and after Acyl-Ghrelin injection

Time frame: 5-6 Hours

Water and sodium transport

Measurement of u-AQP2, u-NCC , u-NKCC -2 and u-ENaC at baseline and after Acyl-Ghrelin

Time frame: 5-6 Hours

Vasoactive hormones

Measurement of p-BNP , PRC, p-AngII , p-Aldo and p-AVP at baseline and after Acyl-Ghrelin

Time frame: 5-6 Hours

Blood pressure

Measurement of Central blood pressure, PWV, AIx and Peripheral blood pressure at baseline and after Acyl-Ghrelin

Time frame: 5-6 Hours

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts