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Ghrelin Decreases Insulin Sensitivity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00512525
First Posted: August 7, 2007
Last Update Posted: September 9, 2009
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:
University of Aarhus
  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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Intravenous Ghrelin Infusion Decreases Insulin Sensitivity in Healthy Young Men

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: End of clamp period ]

Secondary Outcome Measures:
  • Effects on lipolysis [ Time Frame: End of basal and end og clamp period ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
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): NCT00512525


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

Responsible Party: Esben T. Vestergaard, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00512525     History of Changes
Other Study ID Numbers: ETV2007
First Submitted: August 6, 2007
First Posted: August 7, 2007
Last Update Posted: September 9, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs