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Local Metabolic Effects of Ghrelin in Skeletal Muscle and Adipose Tissue

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ClinicalTrials.gov Identifier: NCT01595373
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : January 16, 2013
Sponsor:
Information provided by (Responsible Party):
Esben Thyssen Vestergaard, University of Aarhus

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: Acyl ghrelin Drug: Placebo (Ringer acetate) Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Local Metabolic Effects of Ghrelin: A Clinical Microdialysis Study
Study Start Date : June 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : January 2013

Arm Intervention/treatment
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



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

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


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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

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

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 Posted: May 10, 2012    Key Record Dates
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