ClinicalTrials.Veeva

Menu

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

Rigshospitalet logo

Rigshospitalet

Status

Completed

Conditions

Healthy
Type 2 Diabetes
Endotoxemia

Treatments

Drug: Escherichia Coli Endotoxin

Study type

Interventional

Funder types

Other

Identifiers

NCT00412906
DM2.sa.cim.rh.dk

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 estimated patients

Sex

Male

Ages

25 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy
  • Type 2 diabetes

Exclusion criteria

  • Heart failure
  • Lung disease
  • Anti-coagulation treatment

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems