Renal Tubular Transport Clinical Trial
— DOAGOfficial title:
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.
| Status | Recruiting |
| Enrollment | 15 |
| Est. completion date | January 2018 |
| Est. primary completion date | January 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 40 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Department of Medical Research, Regional Hospital Holstebro | Holstebro |
| Lead Sponsor | Collaborator |
|---|---|
| Erling Bjerregaard Pedersen | University of Aarhus |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Fractional sodium excreation (FENa) | Measurement of FENa at baseline and after Acyl-Ghrelin injection | 5-6 Hours | No |
| Secondary | Renal function | Measurement of GFR, FEK and CH20 at baseline and after Acyl-Ghrelin injection | 5-6 Hours | No |
| Secondary | 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 | No |
| Secondary | Vasoactive hormones | Measurement of p-BNP , PRC, p-AngII , p-Aldo and p-AVP at baseline and after Acyl-Ghrelin | 5-6 Hours | No |
| Secondary | Blood pressure | Measurement of Central blood pressure, PWV, AIx and Peripheral blood pressure at baseline and after Acyl-Ghrelin | 5-6 Hours | No |