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Peripheral Metabolic Effects of Ghrelin

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00771940
First received: October 8, 2008
Last updated: February 2, 2009
Last verified: February 2009
History of Changes
  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 Blind (Subject)
Primary Purpose: Basic Science
Official Title: Peripheral Metabolic Effects of Intra Arterial Ghrelin Infusion in Healthy Controls

Resource links provided by NLM:

U.S. FDA Resources

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
Active Comparator: Ghrelin 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:

  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
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: 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
Study First Received: October 8, 2008
Last Updated: February 2, 2009
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Denmark: National Board of Health

ClinicalTrials.gov processed this record on May 16, 2013