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Pharmacokinetics of Ghrelin

Pharmacokinetics of Ghrelin in Normal Subjects

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00116025
Enrollment
17
Registered
2005-06-27
Start date
2005-03-31
Completion date
2006-01-31
Last updated
2007-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

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.

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.

Interventions

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Human ghrelin half life in healthy subjects

Secondary

MeasureTime frame
Cardiovascular indices (stroke-velocity index, TEI-index)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026