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Endotoxin & Cytokines. Do Protein Loss and Metabolic Effects Depend on Central Nervous System (CNS) Activation of Stress Hormones or on Local Mechanisms in Muscle and Fat?

NCT01452958 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-01-30

No results posted yet for this study

Summary

Main objective :

The purpose of this study is to prove that the effects of bacterial endotoxin and cytokine TNF-α, on protein loss, fatty acid release, and glucose metabolism depend on two mechanisms:

1. Direct local effects in muscle tissue.
2. Activation of the hypothalamo-pituitary axis and a stress-hormone response

Study protocols:

1. Acute metabolic effects of TNF-α(Beromun, Boehringer-Ingelheim Germany) vs placebo perfused into the femoral artery of the leg in 8 healthy subjects.
2. Acute metabolic effects of

* placebo(saline)
* endotoxin(US standard reference E.Coli, endotoxin)
* TNF-α(Beromun, Boehringer-Ingelheim Germany) given systemically
* in 8 patients with hypopituitarism(to block stress hormone release) and in 8 healthy subjects all studied thrice.

Conditions

Interventions

BIOLOGICAL

TNF-alpha

Study protocol 1: 6 ng/kg/h intraarterial Study protocol 2: 18 ng/kg/h intravenous

BIOLOGICAL

Endotoxin

Study protocol 2:0,075 ng/kg/h intravenous

Sponsors & Collaborators

  • University of Aarhus

    collaborator OTHER

  • Lundbeck Foundation

    collaborator OTHER

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Niels Møller, Professor · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01452958 on ClinicalTrials.gov