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

This study has been completed.
Sponsor:
Information provided by:
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00793767
First received: November 18, 2008
Last updated: May 28, 2009
Last verified: May 2009
History of Changes
  Purpose

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.


Condition Intervention
Insulin Sensitivity
 Drug: erythropoietin
Drug: placebo (saline)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Insulin Resistance and Substrate Metabolism After Acute EPO Administration in Healthy Young Men

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 4 and 6 hours post ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Substrate metabolism [ Time Frame: 4 and 6 hours post ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: January 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
placebo
 Drug: placebo (saline)
i.v
Experimental: Erythropoietin
acute administration of erythropoietin
 Drug: erythropoietin
bolus of 400 IU/kg

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793767

Locations
Denmark
Medicinsk forsknings laboratorium
Århus C, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Phd. student, Britt Christensen, Afdeling M, Århus sygehus
ClinicalTrials.gov Identifier: NCT00793767     History of Changes
Other Study ID Numbers: M-20080016
Study First Received: November 18, 2008
Last Updated: May 28, 2009
Health Authority: Denmark: local review board

Keywords provided by Aarhus University Hospital:
Erythropoietin
human muscle tissue
insulin sensitivity
substrate metabolism

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Epoetin Alfa
Insulin
 Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013