|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Rigshospitalet, Denmark |
|---|---|
| Information provided by: | Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT00412906 |
Purpose
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 |
|---|---|
|
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.
Eligibility| Ages Eligible for Study: | 25 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |
| Centre of Inflammaiton and Metabolism, Rigshospitalet | |
| Copenhagen, Denmark, 2100 | |
| Principal Investigator: | Anne Sofie Andreasen, MD | Rogshospitalet, Denmark |
More Information
| 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 |
