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Effects of Free Fatty Acids and 3-hydroxybutyrate on Protein, Glucose, Lipid Metabolism and Intracellular Signals.

University of Aarhus logo

University of Aarhus

Status

Completed

Conditions

Systemic Inflammatory Response Syndrome

Treatments

Other: Endotoxin, US standard reference E.coli

Study type

Interventional

Funder types

Other

Identifiers

NCT01752348
1-10-72-530-12 (Other Identifier)
11422796

Details and patient eligibility

About

The investigators hypothesize that the investigators can detect protein-sparing effects of administration of the ketone 3-hydroxybutyrate and free fatty acids during simulation of an acute inflammatory disease. The investigators use the infusion of endotoxin, US standard reference E.coli in healthy subjects as a model for inflammation / infection and to evaluate the effect on protein metabolism using different tracers and the investigators can measure the various intracellular signaling pathways of selected muscle and adipose tissue.

Enrollment

10 patients

Sex

Male

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 20 < body mass index < 30 kg/m2.
  • written and orally informed consent before enrollment.

Exclusion criteria

  • participation in other studies using radioactive tracers or other exposure to radiation (X-rays, scintigraphy etc).
  • allergy to soy products or eggs
  • diabetes, any type
  • epilepsy
  • ongoing infection
  • immune deficiency
  • cardiovascular disease
  • dysregulated hypertension
  • primary muscles disease, congenital or acquired

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

10 participants in 4 patient groups, including a placebo group

Placebo (isotonic saline)
Placebo Comparator group
Description:
Endotoxin + isotonic saline. Reference for model of acute inflammatory illness
Treatment:
Other: Endotoxin, US standard reference E.coli
Acipimox + Placebo (isotonic saline)
Experimental group
Description:
Endotoxin + Acipimox + Placebo (isotonic saline). Intervention: blockage of endogenous lipolysis.
Treatment:
Other: Endotoxin, US standard reference E.coli
Acipimox + free fatty acids
Experimental group
Description:
Endotoxin + Acipimox + free fatty acids. Intervention: free fatty acids
Treatment:
Other: Endotoxin, US standard reference E.coli
Acipimox + 3-hydroxybutyrate
Experimental group
Description:
Endotoxin + Acipimox + 3-hydroxybutyrate. Intervention: 3-hydroxybutyrate
Treatment:
Other: Endotoxin, US standard reference E.coli

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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