- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00929136
Peripheral Effects of Endotoxin on Insulin Resistance
October 1, 2010 updated by: Aarhus University Hospital
The Effect of Regional Inflammation on Metabolism and Insulin Sensitivity in the Lower Extremity.
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aarhus, Denmark, 8000
- The Medical Research Laboratories, Dept. M, Aarhus University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Normal health
- 22 < BMI < 28
- Written Informed Concent
Exclusion Criteria:
- Any disease
- Any use of medication
- Recent immobilization of a lower extremity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Endotoxin
|
Continuous intra-arterial infusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
glucose concentration
Time Frame: 360 minutes observation
|
360 minutes observation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Regional arteriovenous amino-acid balance
Time Frame: measured at t=180 and 360 minutes
|
measured at t=180 and 360 minutes
|
Intra-cellular insulin signaling
Time Frame: measured at t=0, 120, and, 210 minutes
|
measured at t=0, 120, and, 210 minutes
|
Regional arteriovenous lipid balance
Time Frame: measured at t=180 and 360 minutes
|
measured at t=180 and 360 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
June 22, 2009
First Submitted That Met QC Criteria
June 25, 2009
First Posted (Estimate)
June 26, 2009
Study Record Updates
Last Update Posted (Estimate)
October 4, 2010
Last Update Submitted That Met QC Criteria
October 1, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Aarhus University Hospital
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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