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

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

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 Overview

• Status: Unknown
• Conditions: Renal Tubular Transport
• Intervention / Treatment: Drug: Acyl-Ghrelin

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Holstebro, Denmark, 7500
    • Recruiting
    • Department of Medical Research, Regional Hospital Holstebro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 50 µg Acyl-Ghrelin; Intravenous injection on examination day.	Drug: Acyl-Ghrelin
Active Comparator: 100 µg Acyl-Ghrelin; Intravenous injection on examination day.	Drug: Acyl-Ghrelin
Placebo Comparator: Isotonic Sodium Chloride; Intravenous injection on examination day.	Drug: Acyl-Ghrelin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fractional sodium excreation (FENa)	Measurement of FENa at baseline and after Acyl-Ghrelin injection	5-6 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal function	Measurement of GFR, FEK and CH20 at baseline and after Acyl-Ghrelin injection	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	5-6 Hours
Vasoactive hormones	Measurement of p-BNP , PRC, p-AngII , p-Aldo and p-AVP at baseline and after Acyl-Ghrelin	5-6 Hours
Blood pressure	Measurement of Central blood pressure, PWV, AIx and Peripheral blood pressure at baseline and after Acyl-Ghrelin	5-6 Hours

Collaborators and Investigators

• Sponsor: Erling Bjerregaard Pedersen
• Collaborators: University of Aarhus
• Investigators: Study Chair: Erling B Pedersen, Department of Medical Research and Medicine, Holstebro Regional Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Estimate): August 19, 2015
• Last Update Submitted That Met QC Criteria: August 18, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: MY-1-2014; 2014-004496-23 (EudraCT Number)