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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01752348
First received: December 14, 2012
Last updated: March 25, 2014
Last verified: July 2013
  Purpose

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.


Condition Intervention
Systemic Inflammatory Response Syndrome
Other: Endotoxin, US standard reference E.coli

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: 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.

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Protein metabolism [ Time Frame: 6 hours intervention period ] [ Designated as safety issue: No ]
    Measurements of protein oxidation during intervention using radioactive tracer techniques.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • Other systemic metabolic effects [ Time Frame: 6 hours of intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: February 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo (isotonic saline)
Endotoxin + isotonic saline. Reference for model of acute inflammatory illness
Other: Endotoxin, US standard reference E.coli
Experimental: Acipimox + Placebo (isotonic saline)
Endotoxin + Acipimox + Placebo (isotonic saline). Intervention: blockage of endogenous lipolysis.
Other: Endotoxin, US standard reference E.coli
Experimental: Acipimox + free fatty acids
Endotoxin + Acipimox + free fatty acids. Intervention: free fatty acids
Other: Endotoxin, US standard reference E.coli
Experimental: Acipimox + 3-hydroxybutyrate
Endotoxin + Acipimox + 3-hydroxybutyrate. Intervention: 3-hydroxybutyrate
Other: Endotoxin, US standard reference E.coli

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752348

Locations
Denmark
Medical Research Laboratory, Department of Internal Medicine and Endocrinology
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Niels Møller, Professor Institute of Clinical Medicine, Aarhus University, Denmark. Department of Internal Medicin and Endocrinology, Aarhus university hospital, Aarhus, Denmark.
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01752348     History of Changes
Other Study ID Numbers: 11422796, 1-10-72-530-12
Study First Received: December 14, 2012
Last Updated: March 25, 2014
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
sepsis
cytokine release
fever

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Acipimox
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014