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Ghrelin Decreases Insulin Sensitivity

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00512525
First received: August 6, 2007
Last updated: September 8, 2009
Last verified: September 2009
History of Changes
  Purpose

Ghrelin administration increases appetite and, in rodents, induces weight gain. The aim of this study is to investigate the effect of short term ghrelin administration to humans on metabolism.


Condition Intervention Phase
Healthy Subjects
 Drug: Ghrelin and saline (as placebo)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Intravenous Ghrelin Infusion Decreases Insulin Sensitivity in Healthy Young Men

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: End of clamp period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effects on lipolysis [ Time Frame: End of basal and end og clamp period ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: January 2003
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2 Drug: Ghrelin and saline (as placebo)
Intravenous infusion

Detailed Description:

The current study is initiated in order to assess the impact of acute ghrelin administration on insulin resistance measured by a hyperinsulinemic euglycemic clamp. Second, as free fatty acid is the predominant substrate during fasting, we aim to asses the effects of ghrelin on local and systemic lipolysis.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy men, age >= 18 yr age < 50 yr, body mass index < 27.5 kg/m2above or equal to 18 yr

Exclusion Criteria:

  • any disease, use of prescribed medication, age < 18 yr or >= 50 yr
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512525

Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Ole Schmitz, MD Department of Pharmacology, University of Aarhus, Denmark
  More Information

Additional Information:
Publication  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Esben T. Vestergaard, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00512525     History of Changes
Other Study ID Numbers: ETV2007
Study First Received: August 6, 2007
Last Updated: September 8, 2009
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Denmark: National Board of Health

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013