Peripheral Effects of Endotoxin on Insulin Resistance

Healthy Clinical Trial

Official title:

The Effect of Regional Inflammation on Metabolism and Insulin Sensitivity in the Lower Extremity.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929136
• Other study ID #: Aarhus University Hospital
• Status: Completed
• Phase: N/A
• First received: June 22, 2009
• Last updated: October 1, 2010
• Start date: June 2009
• Est. completion date: May 2010

Study information

• Verified date: October 2010
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to isolate the direct effects of endotoxin on glucose, lipid and protein metabolism. Eight healthy volunteers are enrolled. The hypothesis is that endotoxin will induce insulin resistance, lypolysis and proteolysis acutely.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Normal health

2. 22 < BMI < 28

3. Written Informed Concent

Exclusion Criteria:

1. Any disease

2. Any use of medication

3. Recent immobilization of a lower extremity

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy
• Insulin Resistance

Intervention

Biological:
• USP endotoxin
Continuous intra-arterial infusion

Locations

Country	Name	City	State
Denmark	The Medical Research Laboratories, Dept. M, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucose concentration		360 minutes observation	No
Secondary	Regional arteriovenous amino-acid balance		measured at t=180 and 360 minutes	No
Secondary	Intra-cellular insulin signaling		measured at t=0, 120, and, 210 minutes	No
Secondary	Regional arteriovenous lipid balance		measured at t=180 and 360 minutes	No