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Pharmacokinetics of Ghrelin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00116025
First Posted: June 27, 2005
Last Update Posted: February 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Aarhus
  Purpose
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 Intervention
Healthy Subjects Drug: Human acylated ghrelin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Ghrelin in Normal Subjects

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Human ghrelin half life in healthy subjects

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

Estimated Enrollment: 17
Study Start Date: March 2005
Estimated Study Completion Date: January 2006
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.

  Eligibility

Information from the National Library of Medicine

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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
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
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Jens Otto L Jorgensen, DrMedSc Aarhus University Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00116025     History of Changes
Other Study ID Numbers: 2004/100
2004-002207-33
20040115
First Submitted: June 26, 2005
First Posted: June 27, 2005
Last Update Posted: February 28, 2007
Last Verified: February 2007