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

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT01752348
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 4
• Duration (Months): 21
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Systemic Inflammatory Response Syndrome	Other: Endotoxin, US standard reference E.coli	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• 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.
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Protein metabolism [6 hours intervention period]

   Measurements of protein oxidation during intervention using radioactive tracer techniques.

Secondary Outcome Measures

1. Activated intracellular signalling pathways [study day]

   Measurements on biopsies from muscle and fatty tissue taken on day of study

Other Outcome Measures

1. Other systemic metabolic effects [6 hours of intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT01752348
• Other Study ID Numbers: 11422796; 1-10-72-530-12
• First Posted: Dec 19, 2012
• Last Update Posted: Nov 25, 2014
• Last Verified: Jul 1, 2013

• Keywords provided by University of Aarhus: sepsis; cytokine release; fever
• Additional relevant MeSH terms: Systemic Inflammatory Response Syndrome

Study Results

No Results Posted as of Nov 25, 2014