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Local Metabolic Effects of Ghrelin in Skeletal Muscle and Adipose Tissue

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Esben Thyssen Vestergaard, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01595373
First received: May 7, 2012
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  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)
 Phase 0

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

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Interstitial concentrations of glycerol [ Time Frame: Interstitial concentrations of glycerol at t=120 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Interstitial concentrations of lactate [ Time Frame: Interstitial concentrations of lactate at t=120 minutes ] [ Designated as safety issue: No ]
  • Interstitial concentrations of glucose [ Time Frame: Interstitial concentrations of glucose at t=120 minutes ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Esben Thyssen Vestergaard, Postdoc PhD, University of Aarhus
ClinicalTrials.gov Identifier: NCT01595373     History of Changes
Other Study ID Numbers: 2012-28512
Study First Received: May 7, 2012
Last Updated: January 15, 2013
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
Ghrelin
Microdialysis
Controls
Metabolic effects of ghrelin

ClinicalTrials.gov processed this record on May 16, 2013