NCT00412906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Nov 2006

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

May 21, 2008

Status Verified

May 1, 2008

Enrollment Period

1.4 years

First QC Date

December 18, 2006

Last Update Submit

May 20, 2008

Conditions

HealthyType 2 DiabetesEndotoxemia

Keywords

Low-grade inflammationinsulin resistanceMetabolismType 2 diabetesEndotoxemiaFat tissueMuscle tissueRT-PCR

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Mean Arterial Pressure, heart rate, Temperature,

Interventions

Escherichia Coli EndotoxinDRUG

Eligibility Criteria

Age25 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • Type 2 diabetes

You may not qualify if:

  • Heart failure
  • Lung disease
  • Anti-coagulation treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre of Inflammaiton and Metabolism, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • Andreasen AS, Kelly M, Berg RM, Moller K, Pedersen BK. Type 2 diabetes is associated with altered NF-kappaB DNA binding activity, JNK phosphorylation, and AMPK phosphorylation in skeletal muscle after LPS. PLoS One. 2011;6(9):e23999. doi: 10.1371/journal.pone.0023999. Epub 2011 Sep 13.

    PMID: 21931634DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2EndotoxemiaInsulin Resistance

Interventions

endotoxin, Escherichia coli

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBacteremiaSepsisInfectionsToxemiaSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinism

Study Officials

  • Anne Sofie Andreasen, MD

    Rogshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 18, 2006

First Posted

December 19, 2006

Study Start

November 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

May 21, 2008

Record last verified: 2008-05

Locations

DK(1)