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
  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:


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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Aarhus University Hospital

Additional 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
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 August 01, 2014