Effects of Free Fatty Acids and 3-hydroxybutyrate on Protein, Glucose, Lipid Metabolism and Intracellular Signals.
This study is currently recruiting participants.
Verified March 2013 by University of Aarhus
Sponsor:
University of Aarhus
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01752348
First received: December 14, 2012
Last updated: March 14, 2013
Last verified: March 2013
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752348
Contacts
| Contact: Henrik H Thomsen, M.D. | +45-5072 1835 | henrik.holm.thomsen@ki.au.dk |
| Contact: Niels Møller, Professor | +45-7846 2165 | nielsm@dadlnet.dk |
Locations
| Denmark | |
| Medical Research Laboratory, Department of Internal Medicine and Endocrinology | Recruiting |
| Aarhus C, Denmark, 8000 | |
| Contact: Henrik H Thomsen, M.D. +45-5072 1835 henrik.holm.thomsen@ki.au.dk | |
| Contact: Niels Møller, Professor +45-7846 2165 nielsm@dadlnet.dk | |
| Sub-Investigator: Henrik H Thomsen, M.D. | |
| Principal Investigator: Niels Møller, Professor | |
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 14, 2013 |
| 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 May 19, 2013