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Pharmacokinetics of Ghrelin

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ClinicalTrials.gov Identifier: NCT00116025
Recruitment Status : Completed
First Posted : June 27, 2005
Last Update Posted : February 28, 2007
Sponsor:
Information provided by:
University of Aarhus

Study Description
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Brief Summary:
The main purpose of this study is to determine the half life of the hormone "ghrelin" in the human body. Other purposes are to investigate the effect of ghrelin on appetite and cardiovascular function.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Human acylated ghrelin Not Applicable

Detailed Description:

Ghrelin is a recently described acylated peptide hormone produced by the enteroendocrine cells of the mucosal epithelial layer in the ventricle. Ghrelin is the endogenous ligand for the growth hormone (GH) secretagogue receptor (GHS-R).

Ghrelin stimulates pituitary GH release by binding to the GHS-R at both hypothalamic and pituitary levels.

Several studies show that bolus injections of ghrelin have positive effects on cardiac function in healthy humans as well as in humans with cardiac disease. We investigate the changes in cardiac function during ghrelin infusion in healthy subjects.

The pharmacokinetics of ghrelin is described in few studies only, and we aim to elucidate this aspect further.

Comparisons: In a double blind, placebo controlled, cross over study we investigate the effect of 180 minutes ghrelin infusion on 1. cardiac function (tissue Doppler, stroke-velocity index), 2. vascular tone (a. brachialis dilatation), 3. ghrelin-half-life (acylated and des-acylated) and other pharmacokinetic parameters and 4. effect on appetite.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Ghrelin in Normal Subjects
Study Start Date : March 2005
Study Completion Date : January 2006
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Human ghrelin half life in healthy subjects

Secondary Outcome Measures :
  1. Cardiovascular indices (stroke-velocity index, TEI-index)

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Male
  • BMI < 25 kg/m2
  • Non-smoker
  • Age < 40 yrs

Exclusion Criteria:

  • Any known disease
  • Any medication (except OTCs)
  • Former malignant disease
  • Alcoholism
  • Blood donation (with in 6 months)
  • Allergy to test medication
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116025


Locations
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Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Jens Otto L Jorgensen, DrMedSc Aarhus University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00116025    
Other Study ID Numbers: 2004/100
2004-002207-33
20040115
First Posted: June 27, 2005    Key Record Dates
Last Update Posted: February 28, 2007
Last Verified: February 2007