Ketones Influence on Glucose Metabolism in Brain. A Human Positron Emission Tomography (PET) Study
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2015
CompletedFirst Posted
Study publicly available on registry
February 6, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJanuary 18, 2016
January 1, 2015
10 months
January 26, 2015
January 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Glucose metabolism in brain, CMR
cerebral glucose metabolism measured by PET tracer during the above time frame
t=240-360 minutes
Secondary Outcomes (4)
Stress metabolism
0-360 minutes
Oxygen use
T=150-200 minutes
cerebral blood flow
t=180-250 minutes
Intramuscular signaling
t= 260 minutes
Study Arms (2)
Control
PLACEBO COMPARATORSaline infusion. FDG-PET Scan. O2-PET scan. H2O-PET scan Muscle biopsy
Hyperketonaemia
EXPERIMENTALKetone infusion. FDG-PET Scan. O2-PET scan. H2O-PET scan Muscle biopsy
Interventions
Eligibility Criteria
You may qualify if:
- Healthy
- BMI 20-30 kg/m2
You may not qualify if:
- smoking
- alcohol abuse
- severe comorbidity
- blood donation 6 month prior
- claustrophobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aarhus University Hospital
Aarhus, 8000, Denmark
Related Publications (2)
Lauritzen ES, Svart MV, Voss T, Moller N, Bjerre M. Impact of Acutely Increased Endogenous- and Exogenous Ketone Bodies on FGF21 Levels in Humans. Endocr Res. 2021 Feb;46(1):20-27. doi: 10.1080/07435800.2020.1831015. Epub 2020 Oct 19.
PMID: 33074729DERIVEDLauritsen KM, Sondergaard E, Svart M, Moller N, Gormsen LC. Ketone Body Infusion Increases Circulating Erythropoietin and Bone Marrow Glucose Uptake. Diabetes Care. 2018 Dec;41(12):e152-e154. doi: 10.2337/dc18-1421. Epub 2018 Oct 16. No abstract available.
PMID: 30327354DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mads Svart, MD
Aarhus University / Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2015
First Posted
February 6, 2015
Study Start
March 1, 2015
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
January 18, 2016
Record last verified: 2015-01