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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00412906
Enrollment
48
Registered
2006-12-19
Start date
2006-11-30
Completion date
2008-04-30
Last updated
2008-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotoxemia, Healthy, Type 2 Diabetes

Keywords

Low-grade inflammation, insulin resistance, Metabolism, Type 2 diabetes, Endotoxemia, Fat tissue, Muscle tissue, RT-PCR

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 endotoxin.We 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 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.

Interventions

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
25 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy * Type 2 diabetes

Exclusion criteria

* Heart failure * Lung disease * Anti-coagulation treatment

Design outcomes

Primary

MeasureTime frame
Gene expression evaluated by measuring mRNA via RT-PCR. Plasma cytokine content, PLasma PAI-1 content, endotoxemia score

Secondary

MeasureTime frame
Mean Arterial Pressure, heart rate, Temperature,

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026