Peripheral Effects of Endotoxin on Insulin Resistance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00929136
Recruitment Status : Completed
First Posted : June 26, 2009
Last Update Posted : October 4, 2010
Information provided by:
Aarhus University Hospital

Brief 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.

Condition or disease Intervention/treatment
Healthy Biological: USP endotoxin

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Effect of Regional Inflammation on Metabolism and Insulin Sensitivity in the Lower Extremity.
Study Start Date : June 2009
Primary Completion Date : May 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Endotoxin Biological: USP endotoxin
Continuous intra-arterial infusion
Other Name: USP Endotoxin, LOT: G3E069

Primary Outcome Measures :
  1. glucose concentration [ Time Frame: 360 minutes observation ]

Secondary Outcome Measures :
  1. Regional arteriovenous amino-acid balance [ Time Frame: measured at t=180 and 360 minutes ]
  2. Intra-cellular insulin signaling [ Time Frame: measured at t=0, 120, and, 210 minutes ]
  3. Regional arteriovenous lipid balance [ Time Frame: measured at t=180 and 360 minutes ]

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00929136

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Niels Moller M.D. and Mads Buhl, M.D, University of Aarhus Identifier: NCT00929136     History of Changes
Other Study ID Numbers: Aarhus University Hospital
First Posted: June 26, 2009    Key Record Dates
Last Update Posted: October 4, 2010
Last Verified: October 2010

Keywords provided by Aarhus University Hospital:
Insulin resistance
Intracellular Insulin Signaling
Regional effects of inflammation/endotoxin

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs