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

Insulin Sensitivity Clinical Trial

Official title:

Insulin Resistance and Substrate Metabolism After Acute EPO Administration in Healthy Young Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00793767
• Other study ID #: M-20080016
• Status: Completed
• Phase: N/A
• First received: November 18, 2008
• Last updated: May 28, 2009
• Start date: January 2009

Study information

• Verified date: May 2009
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: local review board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity

Intervention

Drug:
• erythropoietin
bolus of 400 IU/kg
• placebo (saline)
i.v

Locations

Country	Name	City	State
Denmark	Medicinsk forsknings laboratorium	Århus C

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity		4 and 6 hours post	No
Secondary	Substrate metabolism		4 and 6 hours post	No