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Local Metabolic Effects of Ghrelin in Skeletal Muscle and Adipose Tissue

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01595373
First Posted: May 10, 2012
Last Update Posted: January 16, 2013
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 (Responsible Party):
Esben Thyssen Vestergaard, University of Aarhus
  Purpose
The metabolic effects of ghrelin is investigated by microdialysis technique. Subjects are healthy young men. End points are interstitial concentrations of glucose, lactate, and glycerol.

Condition Intervention Phase
Healthy Drug: Acyl ghrelin Drug: Placebo (Ringer acetate) Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Local Metabolic Effects of Ghrelin: A Clinical Microdialysis Study

Further study details as provided by Esben Thyssen Vestergaard, University of Aarhus:

Primary Outcome Measures:
  • Interstitial concentrations of glycerol [ Time Frame: Interstitial concentrations of glycerol at t=120 minutes ]

Secondary Outcome Measures:
  • Interstitial concentrations of lactate [ Time Frame: Interstitial concentrations of lactate at t=120 minutes ]
  • Interstitial concentrations of glucose [ Time Frame: Interstitial concentrations of glucose at t=120 minutes ]

Enrollment: 10
Study Start Date: June 2012
Study Completion Date: January 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ghrelin
Ghrelin
Drug: Acyl ghrelin
Acyl ghrelin 12.5 pg/min infused continuously for 300 minutes
Other Names:
  • Human acyl ghrelin
  • Ghrelin
Placebo Comparator: Placebo
Ringer acetate is used for placebo.
Drug: Placebo (Ringer acetate)
Ringer acetate 2 microliter/min for 300 minutes

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male
  • age 18-65 years (included)
  • Body mass index 20-25 (included)

Exclusion Criteria:

  • alcohol abuse
  • malignant disease
  • use of any medicine except otc painkillers
  • any disease recognized
  • participation in a trial using radioactive isotopes within the last 6 months
  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): NCT01595373


Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Esben Thyssen Vestergaard
Investigators
Principal Investigator: Esben T. Vestergaard, MD PhD University of Aarhus
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Esben Thyssen Vestergaard, Postdoc PhD, University of Aarhus
ClinicalTrials.gov Identifier: NCT01595373     History of Changes
Other Study ID Numbers: 2012-28512
First Submitted: May 7, 2012
First Posted: May 10, 2012
Last Update Posted: January 16, 2013
Last Verified: January 2013

Keywords provided by Esben Thyssen Vestergaard, University of Aarhus:
Ghrelin
Microdialysis
Controls
Metabolic effects of ghrelin