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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Renal Tubular Transport

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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50 µg Acyl-Ghrelin

Intravenous injection on examination day.

Group Type ACTIVE_COMPARATOR

Acyl-Ghrelin

Intervention Type DRUG

100 µg Acyl-Ghrelin

Intravenous injection on examination day.

Group Type ACTIVE_COMPARATOR

Acyl-Ghrelin

Intervention Type DRUG

Isotonic Sodium Chloride

Intravenous injection on examination day.

Group Type PLACEBO_COMPARATOR

Acyl-Ghrelin

Intervention Type DRUG

Interventions

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Acyl-Ghrelin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes