Study of Gene Activity in Fat and Muscle in Diabetics and Healthy Controls

Healthy Clinical Trial

Official title:

Study of Gene Expression in Fat and Muscle Tissue in Type 2 Diabetics and Healthy Controls During Experimental Endotoxemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412906
• Other study ID #: DM2.sa.cim.rh.dk
• Status: Completed
• Phase: N/A
• First received: December 18, 2006
• Last updated: May 20, 2008
• Start date: November 2006
• Est. completion date: April 2008

Study information

• Verified date: May 2008
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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 endotoxin.We hereby hope to gain insight in some mechanisms behind the association between inflammation and insulin resistance.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 80 Years

Eligibility

Inclusion Criteria:

• Healthy

• Type 2 diabetes

Exclusion Criteria:

• Heart failure

• Lung disease

• Anti-coagulation treatment

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Endotoxemia
• Healthy
• Type 2 Diabetes

Intervention

Drug:
• Escherichia Coli Endotoxin

Locations

Country	Name	City	State
Denmark	Centre of Inflammaiton and Metabolism, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression evaluated by measuring mRNA via RT-PCR. Plasma cytokine content, PLasma PAI-1 content, endotoxemia score
Secondary	Mean Arterial Pressure, heart rate, Temperature,