The Effect of Acyl-Ghrelin on Kidney Function and Blood Pressure in Healthy Volunteers
DOAG
2 other identifiers
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 17, 2015
CompletedFirst Posted
Study publicly available on registry
August 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedAugust 19, 2015
August 1, 2015
2.7 years
August 17, 2015
August 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Fractional sodium excreation (FENa)
Measurement of FENa at baseline and after Acyl-Ghrelin injection
5-6 Hours
Secondary Outcomes (4)
Renal function
5-6 Hours
Water and sodium transport
5-6 Hours
Vasoactive hormones
5-6 Hours
Blood pressure
5-6 Hours
Study Arms (3)
50 µg Acyl-Ghrelin
ACTIVE COMPARATORIntravenous injection on examination day.
100 µg Acyl-Ghrelin
ACTIVE COMPARATORIntravenous injection on examination day.
Isotonic Sodium Chloride
PLACEBO COMPARATORIntravenous injection on examination day.
Interventions
Eligibility Criteria
You may qualify if:
- Age 18-40 years,
- BMI 18,5-30kg/m2,
- women must use contraception.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Erling Bjerregaard Pedersenlead
- University of Aarhuscollaborator
Study Sites (1)
Department of Medical Research, Regional Hospital Holstebro
Holstebro, 7500, Denmark
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Erling B Pedersen
Department of Medical Research and Medicine, Holstebro Regional Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, MD, Dr.Sci.
Study Record Dates
First Submitted
August 17, 2015
First Posted
August 19, 2015
Study Start
May 1, 2015
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
August 19, 2015
Record last verified: 2015-08