Study of Gene Activity in Fat and Muscle in Diabetics and Healthy Controls
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Study of Gene Expression in Fat and Muscle Tissue in Type 2 Diabetics and Healthy Controls During Experimental Endotoxemia |
- Gene expression evaluated by measuring mRNA via RT-PCR. Plasma cytokine content, PLasma PAI-1 content, endotoxemia score
- Mean Arterial Pressure, heart rate, Temperature,
| 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:
- Healthy
- Type 2 diabetes
Exclusion Criteria:
- Heart failure
- Lung disease
- Anti-coagulation treatment
Contacts and Locations| Denmark | |
| Centre of Inflammaiton and Metabolism, Rigshospitalet | |
| Copenhagen, Denmark, 2100 | |
| Principal Investigator: | Anne Sofie Andreasen, MD | Rogshospitalet, Denmark |
More Information
No publications provided by Rigshospitalet, Denmark
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Centre of Inflammation and Metabolism, Rigshospitalet |
| ClinicalTrials.gov Identifier: | NCT00412906 History of Changes |
| Other Study ID Numbers: | DM2.sa.cim.rh.dk |
| Study First Received: | December 18, 2006 |
| Last Updated: | May 20, 2008 |
| Health Authority: | Denmark: National Board of Health |
Keywords provided by Rigshospitalet, Denmark:
|
Low-grade inflammation insulin resistance Metabolism Type 2 diabetes |
Endotoxemia Fat tissue Muscle tissue RT-PCR |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Endotoxemia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Bacteremia |
Sepsis Infection Toxemia Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013