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Completed

NCT Number: NCT00116025

Pharmacokinetics of Ghrelin

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human acylated ghrelin

Drug

Primary outcomes

  1. Human ghrelin half life in healthy subjects

Secondary outcomes

  1. Cardiovascular indices (stroke-velocity index, TEI-index)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Pharmacokinetics of Ghrelin in Normal Subjects

Important dates

Study start
2005
Study completion
2006
First posted
Jun 27, 2005
Registry last updated
Feb 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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