Peripheral Metabolic Effects of Ghrelin

This study has been completed.

First Received: October 8, 2008 Last Updated: February 2, 2009 History of Changes

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00771940

Purpose

The aim of this study is to investigate putative peripheral effects of ghrelin on glucose and lipid metabolism in healthy men. Eight subjects will be enrolled. The hypothesis is that ghrelin infusion causes insulin resistance and lipolysis.

Condition	Intervention	Phase
Healthy Controls	Drug: Ghrelin	Phase I

Drug Information available for: Ghrelin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment
Official Title:	Peripheral Metabolic Effects of Intra Arterial Ghrelin Infusion in Healthy Controls

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Plasma levels of glucose [ Time Frame: During study day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Insulin signaling [ Time Frame: Study day ] [ Designated as safety issue: No ]
Serum levels of fatty acids [ Time Frame: Study day ] [ Designated as safety issue: No ]

Estimated Enrollment:	8
Study Start Date:	October 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Ghrelin: Active Comparator	Drug: Ghrelin Solvent, cont. infusion

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

BMI < 27 kg/m2
Written informed consent
Non-smoker

Exclusion Criteria:

Any disease including epilepsy
Any use of medications (excl. paracetamol)
Present or previous malignancy
Alcohol dependency
Allergy to any trial medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771940

Locations

Denmark
Aarhus University Hospital
Aarhus, Denmark, Dk-8000

Sponsors and Collaborators

University of Aarhus

Investigators

Study Director:	Jens Otto L. Jorgensen, MD	Medical Department M, Aarhus University Horpital, Denmark
Principal Investigator:	Esben T Vestergaard, PhD	Medical Department M, Aarhus University Hospital, Denmark

More Information

No publications provided

Responsible Party:	Aarhus University Hospital ( Jens Otto Lunde Jorgensen/MD Professor and Esben T. Vestergaard/MD PhD )
Study ID Numbers:	M-2007008
Study First Received:	October 8, 2008
Last Updated:	February 2, 2009
ClinicalTrials.gov Identifier:	NCT00771940 History of Changes
Health Authority:	Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency; Denmark: Ethics Committee; Denmark: National Board of Health

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 06, 2009