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Ketones Influence on Glucose Metabolism in Brain. A Human Positron Emission Tomography (PET) Study

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: NCT02357550
Recruitment Status : Completed
First Posted : February 6, 2015
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

This project tend to investigate the affection of ketone bodies on brain metabolism. This will be done by measuring human cerebral uptake of energy substrates, together with functional parameters, using PET imaging and appropriate radiotracers under hyperketonemia in healthy subjects by ketone infusion.

Hypotheses

  1. Increased levels of ketone bodies in healthy subjects leads to decreased glucose uptake by brain cells contributing to hyperglycaemia.
  2. Increased levels of ketone bodies in healthy subjects leads to increased cerebral blood flow.
  3. Altered oxygen consumption during hyperketonemia in healthy subjects.

Condition or disease Intervention/treatment Phase
Ketone Body Metabolism Brain Metabolism Drug: ketone Drug: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Ketones Influence on Glucose Metabolism in Brain. A Human Positron Emission Tomography (PET) Study
Study Start Date : March 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Placebo Comparator: Control
Saline infusion. FDG-PET Scan. O2-PET scan. H2O-PET scan Muscle biopsy
Drug: placebo
Saline infusion.

Experimental: Hyperketonaemia
Ketone infusion. FDG-PET Scan. O2-PET scan. H2O-PET scan Muscle biopsy
Drug: ketone
3-OHB is infused intravenously.




Primary Outcome Measures :
  1. Glucose metabolism in brain, CMR [ Time Frame: t=240-360 minutes ]
    cerebral glucose metabolism measured by PET tracer during the above time frame


Secondary Outcome Measures :
  1. Stress metabolism [ Time Frame: 0-360 minutes ]
    growth hormone, cortisol, glucagon, adrenalin, ghrelin.

  2. Oxygen use [ Time Frame: T=150-200 minutes ]
    cerebral oxygen consumption measured by PET tracer during the above time frame

  3. cerebral blood flow [ Time Frame: t=180-250 minutes ]
    cerebral blood flow measured by PET tracer during the above time frame

  4. Intramuscular signaling [ Time Frame: t= 260 minutes ]
    protein and insulin signaling in muscle



Information from the National Library of Medicine

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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
  • BMI 20-30 kg/m2

Exclusion Criteria:

  • smoking
  • alcohol abuse
  • severe comorbidity
  • blood donation 6 month prior
  • 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): NCT02357550


Locations
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Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Mads Svart, MD Aarhus University / 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: NCT02357550    
Other Study ID Numbers: RM-1-10-72-106-14
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2015