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Sponsored by: |
Rigshospitalet, Denmark |
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Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00412906 |
The aim of the present protocol is to study gene activity in fat and muscle tissue in type 2 diabetics and healthy volunteers after injection of E. coli endotoxin.We hereby hope to gain insight in some mechanisms behind the association between inflammation and insulin resistance.
Condition | Intervention |
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Healthy Type 2 Diabetes Endotoxemia |
Drug: Escherichia Coli Endotoxin |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Study of Gene Expression in Fat and Muscle Tissue in Type 2 Diabetics and Healthy Controls During Experimental Endotoxemia |
Estimated Enrollment: | 48 |
Study Start Date: | November 2006 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 25 Years to 80 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Centre of Inflammaiton and Metabolism, Rigshospitalet | |
Copenhagen, Denmark, 2100 |
Principal Investigator: | Anne Sofie Andreasen, MD | Rogshospitalet, Denmark |
Responsible Party: | Rigshospitalet ( Centre of Inflammation and Metabolism ) |
Study ID Numbers: | DM2.sa.cim.rh.dk |
Study First Received: | December 18, 2006 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00412906 |
Health Authority: | Denmark: National Board of Health |
Low-grade inflammation insulin resistance Metabolism Type 2 diabetes |
Endotoxemia Fat tissue Muscle tissue RT-PCR |
Systemic Inflammatory Response Syndrome Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Bacteremia Healthy Insulin Toxemia |
Inflammation Sepsis Diabetes Mellitus, Type 2 Endotoxemia Endocrinopathy Insulin Resistance Metabolic disorder Glucose Metabolism Disorders |
Pathologic Processes Infection |