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Effects of Experimental Hyperketonemia on Myocardial Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02814474
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : July 4, 2016
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

Starvation and metabolic stress increase circulating ketone bodies, potentially providing the heart with an alternative oxidative fuel. Hyperketonemia reduces myocardial fatty acid consumption. It is unclear whether this is due to inhibited peripheral lipolysis or diminished uptake per se.

Aim: To test whether infusion of 3-hydroxybutyrate (BHB) inhibits myocardial glucose and fatty acid uptake.

Methods: Randomized, single blinded, cross-over interventional study in 8 healthy volunteers. Myocardial glucose and fatty acid metabolism studied by 11C-palmitate and 18F-FDG PET/CT. Experimental elevation of circulating ketone bodies by infusion of β-hydroxy-β-methylbutyrate.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: Na-3-hydroxybutyrate Other: Saline Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Impact of Ketone Bodies on Myocardial Glucose and Fatty Acid Metabolism in Healthy Volunteers: A Positron Emission Tomography Study
Study Start Date : October 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Placebo Comparator: SALINE
Infusion of saline (0.9 %)
Other: Saline
Infusion of 0.9 % saline

Experimental: KETONE
Infusion of Na-3-Hydroxybutyrate (0.18 g/kg/hour) for 390 minutes
Other: Na-3-hydroxybutyrate
Infusion of Na-3-hydroxybutyrate (0.18 g/kg/hour) for 390 minutes




Primary Outcome Measures :
  1. Myocardial Glucose uptake [ Time Frame: After 330 minutes of ketone infusion ]
    Dynamic 18F-FDG PET/CT scan - 50 minutes

  2. Myocardial Fatty Acid Metabolism [ Time Frame: After 210 minutes of ketone infusion ]
    Dynamic 11C-palmitate PET/CT scan - 50 minutes

  3. Myocardial Blood Flow [ Time Frame: After 180 minutes of ketone infusion ]
    Dynamic 15O-H2O PET/CT scan - 6 minutes


Secondary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: Time 0-390 of the ketone body infusion ]
    Glucose infusion rate (GIR) during a 0.3 mIE/kg/min hyperinsulinemic- euglycemic clamp



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Decreased cardiac function
  • Kidney disease
  • Pulmonary disease
  • Current malignant disease
  • Substance abuse
  • Blood donation within 6 month prior to the study
  • Participation in studies involving ionising radiation within 12 month prior to the study
  • Known claustrophobia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814474


Locations
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Denmark
Department of Nuclear Medicine & PET Center, Aarhus University Hospital
Aarhus, Denmark, 8000
Medical Research Laboratories
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
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Study Chair: Niels Møller, MD DMsc Aarhus University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02814474    
Other Study ID Numbers: 1-10-72-104-14
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: June 2016
Keywords provided by University of Aarhus:
PET/CT
Heart failure
hydroxybutyrate