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

Phase 1

• Conditions: Renal Tubular Transport
• Interventions: Drug: Acyl-Ghrelin

• Registration Number: NCT02528422
• Lead Sponsor: Erling Bjerregaard Pedersen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Status Verified: 2015-08
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-18
• Last Update Submitted: 2015-08-18
• Study First Posted: 2015-08-19
• Last Update Posted: 2015-08-19
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
100 µg Acyl-Ghrelin	Acyl-Ghrelin	Intravenous injection on examination day.
Isotonic Sodium Chloride	Acyl-Ghrelin	Intravenous injection on examination day.
50 µg Acyl-Ghrelin	Acyl-Ghrelin	Intravenous injection on examination day.

Primary Outcome Measures

Name	Time	Method
Fractional sodium excreation (FENa)	5-6 Hours	Measurement of FENa at baseline and after Acyl-Ghrelin injection

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Medical Research, Regional Hospital Holstebro; 🇩🇰 Holstebro, Denmark