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Peripheral Metabolic Effects of Ghrelin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00771940
First Posted: October 15, 2008
Last Update Posted: February 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Aarhus
  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 1

Study Type: Interventional
Study Design: 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

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Plasma levels of glucose [ Time Frame: During study day ]

Secondary Outcome Measures:
  • Insulin signaling [ Time Frame: Study day ]
  • Serum levels of fatty acids [ Time Frame: Study day ]

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
Active Comparator: Ghrelin Drug: Ghrelin
Solvent, cont. infusion

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jens Otto Lunde Jorgensen/MD Professor and Esben T. Vestergaard/MD PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00771940     History of Changes
Other Study ID Numbers: M-2007008
First Submitted: October 8, 2008
First Posted: October 15, 2008
Last Update Posted: February 3, 2009
Last Verified: February 2009