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NCT00116025 Clinical Trial

Pharmacokinetics of Ghrelin

Healthy Subjects Clinical Trial

Official title:
Pharmacokinetics of Ghrelin in Normal Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00116025
Other study ID # 2004/100
Secondary ID 2004-002207-3320
Status Completed
Phase N/A
First received June 26, 2005
Last updated February 27, 2007
Start date March 2005
Est. completion date January 2006

Study information
Verified date February 2007
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Human acylated ghrelin

Locations
Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Human ghrelin half life in healthy subjects
Secondary Cardiovascular indices (stroke-velocity index, TEI-index)
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