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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
  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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov processed this record on February 20, 2017