Study of Gene Activity in Fat and Muscle in Diabetics and Healthy Controls
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|ClinicalTrials.gov Identifier: NCT00412906|
Recruitment Status : Completed
First Posted : December 19, 2006
Last Update Posted : May 21, 2008
|Condition or disease||Intervention/treatment||Phase|
|Healthy Type 2 Diabetes Endotoxemia||Drug: Escherichia Coli Endotoxin||Not Applicable|
Numerous studies have shown an association between low-grade inflammation and insulin-resistance in type 2 diabetics. It is also well-known that septic patients often develop insulin-resistance. The pathogenetic mechanisms behind the association between inflammation and insulin-resistance is not fully understood.
In this study we create an experimental inflammation by giving E. coli endotoxin 0,3 ng/kg iv to type 2 diabetics and healthy controls. Muscle biopsies are taken at 0, 2, 4 and 6 hours after injection, while fat biopsies are taken 0, 2, 4, 6 and 8 hours after endotoxin. mRNA for adiponectin, leptin, PPAR-gamma, PGC-1, PAI-1 and cytokines in tissue is later measured by RT-PCR.
Blood samples are drawn on an hourly basis until 8 hours after endotoxin injection for common biochemical analyses including white blood cell count. Plasma is spared and later analyzed for cytokines, PAI-1 and VCAM-1/ICAM-1.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Gene Expression in Fat and Muscle Tissue in Type 2 Diabetics and Healthy Controls During Experimental Endotoxemia|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
- Gene expression evaluated by measuring mRNA via RT-PCR. Plasma cytokine content, PLasma PAI-1 content, endotoxemia score
- Mean Arterial Pressure, heart rate, Temperature,
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): NCT00412906
|Centre of Inflammaiton and Metabolism, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Anne Sofie Andreasen, MD||Rogshospitalet, Denmark|