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Peripheral Effects of Endotoxin on Insulin Resistance

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
USP endotoxin
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring Endotoxin, Insulin resistance, Lipolysis, Proteolysis, Intracellular Insulin Signaling, Regional effects of inflammation/endotoxin

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • The Medical Research Laboratories, Dept. M, Aarhus University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endotoxin

Arm Description

Outcomes

Primary Outcome Measures

glucose concentration

Secondary Outcome Measures

Regional arteriovenous amino-acid balance
Intra-cellular insulin signaling
Regional arteriovenous lipid balance

Full Information

First Posted
June 22, 2009
Last Updated
October 1, 2010
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00929136
Brief Title
Peripheral Effects of Endotoxin on Insulin Resistance
Official Title
The Effect of Regional Inflammation on Metabolism and Insulin Sensitivity in the Lower Extremity.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Endotoxin, Insulin resistance, Lipolysis, Proteolysis, Intracellular Insulin Signaling, Regional effects of inflammation/endotoxin

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endotoxin
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
USP endotoxin
Other Intervention Name(s)
USP Endotoxin, LOT: G3E069
Intervention Description
Continuous intra-arterial infusion
Primary Outcome Measure Information:
Title
glucose concentration
Time Frame
360 minutes observation
Secondary Outcome Measure Information:
Title
Regional arteriovenous amino-acid balance
Time Frame
measured at t=180 and 360 minutes
Title
Intra-cellular insulin signaling
Time Frame
measured at t=0, 120, and, 210 minutes
Title
Regional arteriovenous lipid balance
Time Frame
measured at t=180 and 360 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mads Buhl, M.D.
Organizational Affiliation
Medical Department M (Endocrinology and Diabetes), Århus University Hospital, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Niels Moller, M.D., professor, Dmsc
Organizational Affiliation
Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
The Medical Research Laboratories, Dept. M, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
23543661
Citation
Buhl M, Bosnjak E, Vendelbo MH, Gjedsted J, Nielsen RR, K-Hafstrom T, Vestergaard ET, Jessen N, Tonnesen E, Moller AB, Pedersen SB, Pilegaard H, Bienso RS, Jorgensen JO, Moller N. Direct effects of locally administered lipopolysaccharide on glucose, lipid, and protein metabolism in the placebo-controlled, bilaterally infused human leg. J Clin Endocrinol Metab. 2013 May;98(5):2090-9. doi: 10.1210/jc.2012-3836. Epub 2013 Mar 29.
Results Reference
derived

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Peripheral Effects of Endotoxin on Insulin Resistance

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