Pharmacokinetics of Ghrelin

Pharmacokinetics of Ghrelin in Normal Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Human acylated ghrelin

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.

• Study Type: Interventional
• Enrollment: 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Human ghrelin half life in healthy subjects

Secondary Outcome Measures

Outcome Measure
Cardiovascular indices (stroke-velocity index, TEI-index)

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Jens Otto L Jorgensen, DrMedSc, Aarhus University Hospital

Publications and helpful links

General Publications

• Vestergaard ET, Gormsen LC, Jessen N, Lund S, Hansen TK, Moller N, Jorgensen JO. Ghrelin infusion in humans induces acute insulin resistance and lipolysis independent of growth hormone signaling. Diabetes. 2008 Dec;57(12):3205-10. doi: 10.2337/db08-0025. Epub 2008 Sep 5.

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Study Completion: January 1, 2006

Study Registration Dates

• First Submitted: June 26, 2005
• First Submitted That Met QC Criteria: June 27, 2005
• First Posted (ESTIMATE): June 27, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): February 28, 2007
• Last Update Submitted That Met QC Criteria: February 27, 2007
• Last Verified: February 1, 2007

More Information

Terms related to this study

• Other Study ID Numbers: 2004/100; 2004-002207-33; 20040115