Insulin Resistance and Substrate Metabolism After Acute EPO Administration - Full Text View

Sponsored by:	Aarhus University Hospital
Information provided by:	Aarhus University Hospital
ClinicalTrials.gov Identifier:	NCT00793767

Purpose

Recently EPO receptors have been found in human muscle tissue, but what is still not known are the physiological role of these receptors. In this study the investigators 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 Other: saline

Drug Information available for: Epoetin alfa Erythropoietin Insulin Sodium chloride

U.S. FDA Resources

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

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
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
placebo: Placebo Comparator placebo	Other: saline i.v
Erythropoietin: Experimental acute administration of erythropoietin	Drug: erythropoietin bolus of 400 IU/kg

Detailed Description:

Recently EPO receptors have been found i human muscle tissue, but it is still not known was 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

Contacts

Contact: Britt Christensen

+45 89492035

Locations

Denmark
Medicinsk forsknings laboratorium
Århus C, Denmark, 8000

Sponsors and Collaborators

Aarhus University Hospital

More Information

Responsible Party:	Afdeling M, Århus sygehus ( Phd. student, Britt Christensen )
Study ID Numbers:	M-20080016
Study First Received:	November 18, 2008
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00793767
Health Authority:	Denmark: local review board

Keywords provided by Aarhus University Hospital:

Erythropoietin
human muscle tissue
insulin sensitivity
substrate metabolism

Study placed in the following topic categories:

Epoetin Alfa
Hyperinsulinism
Metabolic Diseases
Healthy

Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Hematinics
Therapeutic Uses

Physiological Effects of Drugs
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009