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Peripheral Effects of Endotoxin on Insulin Resistance

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ClinicalTrials.gov Identifier: NCT00929136
Recruitment Status : Completed
First Posted : June 26, 2009
Last Update Posted : October 4, 2010
Sponsor:
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 Phase
Healthy Biological: USP endotoxin Not Applicable

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
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

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
Criteria

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 ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: June 26, 2009    Key Record Dates
Last Update Posted: October 4, 2010
Last Verified: October 2010

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

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