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Insulin Resistance and Substrate Metabolism After Acute Erythropoietin (EPO) Administration

Primary Purpose

Insulin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
erythropoietin
placebo (saline)
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Sensitivity focused on measuring Erythropoietin, human muscle tissue, insulin sensitivity, substrate metabolism

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Medicinsk forsknings laboratorium

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

Erythropoietin

Arm Description

placebo

acute administration of erythropoietin

Outcomes

Primary Outcome Measures

Insulin sensitivity

Secondary Outcome Measures

Substrate metabolism

Full Information

First Posted
November 18, 2008
Last Updated
May 28, 2009
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00793767
Brief Title
Insulin Resistance and Substrate Metabolism After Acute Erythropoietin (EPO) Administration
Official Title
Insulin Resistance and Substrate Metabolism After Acute EPO Administration in Healthy Young Men
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity
Keywords
Erythropoietin, human muscle tissue, insulin sensitivity, substrate metabolism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
Erythropoietin
Arm Type
Experimental
Arm Description
acute administration of erythropoietin
Intervention Type
Drug
Intervention Name(s)
erythropoietin
Intervention Description
bolus of 400 IU/kg
Intervention Type
Drug
Intervention Name(s)
placebo (saline)
Intervention Description
i.v
Primary Outcome Measure Information:
Title
Insulin sensitivity
Time Frame
4 and 6 hours post
Secondary Outcome Measure Information:
Title
Substrate metabolism
Time Frame
4 and 6 hours post

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Medicinsk forsknings laboratorium
City
Århus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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Insulin Resistance and Substrate Metabolism After Acute Erythropoietin (EPO) Administration

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