Peripheral Metabolic Effects of Ghrelin

Healthy Controls Clinical Trial

Official title:

Peripheral Metabolic Effects of Intra Arterial Ghrelin Infusion in Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771940
• Other study ID #: M-2007008
• Status: Completed
• Phase: Phase 1
• First received: October 8, 2008
• Last updated: February 2, 2009
• Start date: October 2008
• Est. completion date: January 2009

Study information

• Verified date: February 2009
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics CommitteeDenmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Controls

Intervention

Drug:
• Ghrelin
Solvent, cont. infusion

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma levels of glucose		During study day	No
Secondary	Insulin signaling		Study day	No
Secondary	Serum levels of fatty acids		Study day	No