Peripheral Effects of Endotoxin on Insulin Resistance

This study has been completed.

Sponsor:

Information provided by:

Aarhus University Hospital

ClinicalTrials.gov Identifier:

NCT00929136

First received: June 22, 2009

Last updated: October 1, 2010

Last verified: October 2010

History of Changes

Purpose

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.

Condition	Intervention
Healthy	Biological: USP endotoxin

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science
Official Title:	The Effect of Regional Inflammation on Metabolism and Insulin Sensitivity in the Lower Extremity.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Insulin human

U.S. FDA Resources

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:

glucose concentration [ Time Frame: 360 minutes observation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Regional arteriovenous amino-acid balance [ Time Frame: measured at t=180 and 360 minutes ] [ Designated as safety issue: No ]
Intra-cellular insulin signaling [ Time Frame: measured at t=0, 120, and, 210 minutes ] [ Designated as safety issue: No ]
Regional arteriovenous lipid balance [ Time Frame: measured at t=180 and 360 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	8
Study Start Date:	June 2009
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Endotoxin	Biological: USP endotoxin Continuous intra-arterial infusion Other Name: USP Endotoxin, LOT: G3E069

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Normal health
22 < BMI < 28
Written Informed Concent

Exclusion Criteria:

Any disease
Any use of medication
Recent immobilization of a lower extremity

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929136

Locations

Denmark
The Medical Research Laboratories, Dept. M, Aarhus University Hospital
Aarhus, Denmark, 8000

Sponsors and Collaborators

Aarhus University Hospital

Investigators

Principal Investigator:	Mads Buhl, M.D.	Medical Department M (Endocrinology and Diabetes), Århus University Hospital, Denmark
Study Director:	Niels Moller, M.D., professor, Dmsc	Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital, Denmark

More Information

No publications provided

Responsible Party:	Niels Moller M.D. and Mads Buhl, M.D, University of Aarhus
ClinicalTrials.gov Identifier:	NCT00929136 History of Changes
Other Study ID Numbers:	Aarhus University Hospital
Study First Received:	June 22, 2009
Last Updated:	October 1, 2010
Health Authority:	Denmark: Danish Dataprotection Agency Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: Danish Medicines Agency

Keywords provided by Aarhus University Hospital:

Endotoxin
Insulin resistance
Lipolysis

Proteolysis
Intracellular Insulin Signaling
Regional effects of inflammation/endotoxin

Additional relevant MeSH terms:

Inflammation
Insulin Resistance
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders

Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013

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