- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00793767
Insulin Resistance and Substrate Metabolism After Acute Erythropoietin (EPO) Administration
May 28, 2009 updated by: Aarhus University Hospital
Insulin Resistance and Substrate Metabolism After Acute EPO Administration in Healthy Young Men
Recently EPO receptors have been found in human muscle tissue, but what is still not known is the physiological role of these receptors.
In this study the researchers want to investigate if there is any effect of a acute administration of EPO on insulin resistance and/or substrate metabolism in muscle tissue.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Recently EPO receptors have been found in human muscle tissue, but what is still not known is what the physiological role of these receptors are.
It has previously been shown that Growth Hormone mediate insulin resistance.
The GH receptor and EPO receptor belong to the same family of cytokine receptors, and thereby share many of the same signalling pathways.
In this study we want to investigate if there is a similar effect on insulin resistance and/or substrate metabolism after acute administration of EPO in human muscle tissue.
Different signalling pathways are investigated på western blotting, and insulin sensitivity are measured be a hyperinsulinemic euglycemic clamp, and substrate metabolism is measured by the forearm model.
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Århus C, Denmark, 8000
- Medicinsk forsknings laboratorium
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy persons
- Between 18 and 30 years
- Normal weight (BMI: 18-25)
Exclusion Criteria:
- Severe heart disease (NYHA 3)
- Uncontrolled hypertension
- Previous cerebrovascular disease
- Proliferative retinopathy
- Diabetes
- Musculo-skeletal diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
|
i.v
|
Experimental: Erythropoietin
acute administration of erythropoietin
|
bolus of 400 IU/kg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Insulin sensitivity
Time Frame: 4 and 6 hours post
|
4 and 6 hours post
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Substrate metabolism
Time Frame: 4 and 6 hours post
|
4 and 6 hours post
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
November 18, 2008
First Submitted That Met QC Criteria
November 18, 2008
First Posted (Estimate)
November 19, 2008
Study Record Updates
Last Update Posted (Estimate)
May 29, 2009
Last Update Submitted That Met QC Criteria
May 28, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M-20080016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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