Peripheral Metabolic Effects of Ghrelin

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT00771940
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Healthy Controls	Drug: Ghrelin	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Peripheral Metabolic Effects of Intra Arterial Ghrelin Infusion in Healthy Controls
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ghrelin	Drug: Ghrelin; Solvent, cont. infusion

Outcome Measures

Primary Outcome Measures

1. Plasma levels of glucose [During study day]

Secondary Outcome Measures

1. Insulin signaling [Study day]

2. Serum levels of fatty acids [Study day]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. BMI < 27 kg/m2

2. Written informed consent

3. Non-smoker

Exclusion Criteria:

1. Any disease including epilepsy

2. Any use of medications (excl. paracetamol)

3. Present or previous malignancy

4. Alcohol dependency

5. Allergy to any trial medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00771940
• Other Study ID Numbers: M-2007008
• First Posted: Oct 15, 2008
• Last Update Posted: Feb 3, 2009
• Last Verified: Feb 1, 2009

Study Results

No Results Posted as of Feb 3, 2009