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

Erling Bjerregaard Pedersen

Status and phase: Unknown; Phase 1

Conditions: Renal Tubular Transport

Treatments: Drug: Acyl-Ghrelin

Study type: Interventional

Funder types: Other

Identifiers

NCT02528422

MY-1-2014

2014-004496-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 3 patient groups, including a placebo group

50 µg Acyl-Ghrelin

Active Comparator group

Description:

Intravenous injection on examination day.

Treatment:

Drug: Acyl-Ghrelin

100 µg Acyl-Ghrelin

Active Comparator group

Description:

Intravenous injection on examination day.

Treatment:

Drug: Acyl-Ghrelin

Isotonic Sodium Chloride

Placebo Comparator group

Description:

Intravenous injection on examination day.

Treatment:

Drug: Acyl-Ghrelin