Viewing Study NCT00412906



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Study NCT ID: NCT00412906
Status: COMPLETED
Last Update Posted: 2008-05-21
First Post: 2006-12-18

Brief Title: Study of Gene Activity in Fat and Muscle in Diabetics and Healthy Controls
Sponsor: Rigshospitalet Denmark
Organization: Rigshospitalet Denmark

Study Overview

Official Title: Study of Gene Expression in Fat and Muscle Tissue in Type 2 Diabetics and Healthy Controls During Experimental Endotoxemia
Status: COMPLETED
Status Verified Date: 2008-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 endotoxinWe hereby hope to gain insight in some mechanisms behind the association between inflammation and insulin resistance
Detailed Description: 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 03 ngkg 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-1ICAM-1

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None