Pharmacokinetics of Ghrelin

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00116025
First received: June 26, 2005
Last updated: February 27, 2007
Last verified: February 2007
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Aarhus

Additional 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
Study First Received: June 26, 2005
Last Updated: February 27, 2007
Health Authority: Denmark: Danish Medicines Agency

ClinicalTrials.gov processed this record on April 21, 2014