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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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31 August 2015 |
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Main ID: |
NCT02528422 |
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Date of registration:
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17/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Acyl-Ghrelin on Kidney Function and Blood Pressure in Healthy Volunteers
DOAG |
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Scientific title:
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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 |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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15 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02528422 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
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Phase:
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Phase 1
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Erling B Pedersen |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Medical Research and Medicine, Holstebro Regional Hospital |
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Name:
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My ES Malmberg |
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Address:
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Telephone:
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+4578436588 |
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Email:
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mymalmbe@rm.dk |
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Affiliation:
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Renal Tubular Transport
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Intervention(s)
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Drug: Acyl-Ghrelin
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Primary Outcome(s)
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Fractional sodium excreation (FENa)
[Time Frame: 5-6 Hours]
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Secondary Outcome(s)
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Water and sodium transport
[Time Frame: 5-6 Hours]
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Vasoactive hormones
[Time Frame: 5-6 Hours]
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Blood pressure
[Time Frame: 5-6 Hours]
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Renal function
[Time Frame: 5-6 Hours]
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Secondary ID(s)
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2014-004496-23
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MY-1-2014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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