Back to resultsGhrelin Decreases Insulin Sensitivity
Primary Purpose
Healthy Subjects
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ghrelin and saline (as placebo)
Sponsored by
About this trial
This is an interventional health services research trial for Healthy Subjects
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
2
Arm Description
Outcomes
Primary Outcome Measures
Insulin sensitivity
Secondary Outcome Measures
Effects on lipolysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00512525
Brief Title
Ghrelin Decreases Insulin Sensitivity
Official Title
Intravenous Ghrelin Infusion Decreases Insulin Sensitivity in Healthy Young Men
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ghrelin and saline (as placebo)
Intervention Description
Intravenous infusion
Primary Outcome Measure Information:
Title
Insulin sensitivity
Time Frame
End of clamp period
Secondary Outcome Measure Information:
Title
Effects on lipolysis
Time Frame
End of basal and end og clamp period
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole Schmitz, MD
Organizational Affiliation
Department of Pharmacology, University of Aarhus, Denmark
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Ghrelin Decreases Insulin Sensitivity
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