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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01752348
First received: December 14, 2012
Last updated: November 24, 2014
Last verified: July 2013

December 14, 2012
November 24, 2014
February 2013
July 2014   (final data collection date for primary outcome measure)
Protein metabolism [ Time Frame: 6 hours intervention period ] [ Designated as safety issue: No ]
Measurements of protein oxidation during intervention using radioactive tracer techniques.
Same as current
Complete list of historical versions of study NCT01752348 on ClinicalTrials.gov Archive Site
Activated intracellular signalling pathways [ Time Frame: study day ] [ Designated as safety issue: No ]
Measurements on biopsies from muscle and fatty tissue taken on day of study
Same as current
Other systemic metabolic effects [ Time Frame: 6 hours of intervention ] [ Designated as safety issue: No ]
Same as current
 
Effects of Free Fatty Acids and 3-hydroxybutyrate on Protein, Glucose, Lipid Metabolism and Intracellular Signals.
Effects of Free Fatty Acids and 3-hydroxybutyrate on Protein, Glucose, Lipid Metabolism and Intracellular Signals; a Study on Muscle Wasting and Metabolism During Acute Inflammation and Potential Anabolic Mechanisms.

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Systemic Inflammatory Response Syndrome
Other: Endotoxin, US standard reference E.coli
  • Placebo Comparator: Placebo (isotonic saline)
    Endotoxin + isotonic saline. Reference for model of acute inflammatory illness
    Intervention: Other: Endotoxin, US standard reference E.coli
  • Experimental: Acipimox + Placebo (isotonic saline)
    Endotoxin + Acipimox + Placebo (isotonic saline). Intervention: blockage of endogenous lipolysis.
    Intervention: Other: Endotoxin, US standard reference E.coli
  • Experimental: Acipimox + free fatty acids
    Endotoxin + Acipimox + free fatty acids. Intervention: free fatty acids
    Intervention: Other: Endotoxin, US standard reference E.coli
  • Experimental: Acipimox + 3-hydroxybutyrate
    Endotoxin + Acipimox + 3-hydroxybutyrate. Intervention: 3-hydroxybutyrate
    Intervention: Other: Endotoxin, US standard reference E.coli
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
November 2014
July 2014   (final data collection date for primary outcome measure)

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
Male
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01752348
11422796, 1-10-72-530-12
Yes
University of Aarhus
University of Aarhus
Not Provided
Principal Investigator: Niels Møller, Professor Institute of Clinical Medicine, Aarhus University, Denmark. Department of Internal Medicin and Endocrinology, Aarhus university hospital, Aarhus, Denmark.
University of Aarhus
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP