Ketone Body MetabolismNCT02357550
Ketones Influence on Glucose Metabolism in Brain. A Human Positron Emission Tomography (PET) Study
A study testing ketone in people with Ketone Body Metabolism and Brain Metabolism, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketone Body Metabolism, Brain Metabolism
- What is being tested?
- ketone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- BMI 20-30 kg/m2
Who cannot join
- smoking
- alcohol abuse
- severe comorbidity
- blood donation 6 month prior
- claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
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
- Increased levels of ketone bodies in healthy subjects leads to decreased glucose uptake by brain cells contributing to hyperglycaemia.
- Increased levels of ketone bodies in healthy subjects leads to increased cerebral blood flow.
- Altered oxygen consumption during hyperketonemia in healthy subjects.
- Conditions
- Ketone Body Metabolism, Brain Metabolism
- Being tested
- ketone, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketoneDrug
3-OHB is infused intravenously.
placeboDrug
Saline infusion.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Saline infusion. FDG-PET Scan. O2-PET scan. H2O-PET scan Muscle biopsy Receives: Drug: placebo |
| Hyperketonaemia | Experimental | Ketone infusion. FDG-PET Scan. O2-PET scan. H2O-PET scan Muscle biopsy Receives: Drug: ketone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose metabolism in brain, CMR
cerebral glucose metabolism measured by PET tracer during the above time frame
Measured: t=240-360 minutes
Secondary outcomes (4)
Stress metabolism
growth hormone, cortisol, glucagon, adrenalin, ghrelin.
Measured: 0-360 minutes
Oxygen use
cerebral oxygen consumption measured by PET tracer during the above time frame
Measured: T=150-200 minutes
cerebral blood flow
cerebral blood flow measured by PET tracer during the above time frame
Measured: t=180-250 minutes
Intramuscular signaling
protein and insulin signaling in muscle
Measured: t= 260 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ketone Body MetabolismStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mads Svart, MD, Principal investigator, Aarhus University / Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357550
- Sponsor's protocol ID
- RM-1-10-72-106-14
- Status last verified
- Jan 2015
- First submitted
- 26 Jan 2015
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33074729Lauritsen 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.
PubMed 30327354
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketones Influence on Glucose Metabolism in Brain. A Human Positron Emission Tomography (PET) Study
- ClinicalTrials.gov ID
- NCT02357550
- Acronym / sponsor ID
- RM-1-10-72-106-14
- Conditions
- Ketone Body Metabolism, Brain Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Increased levels of ketone bodies in healthy subjects leads to decreased glucose uptake by brain cells contributing to hyperglycaemia.
- Increased levels of ketone bodies in healthy subjects leads to increased cerebral blood flow.
- Altered oxygen consumption during hyperketonemia in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: placeboSaline infusion. FDG-PET Scan. O2-PET scan. H2O-PET scan Muscle biopsy |
| Hyperketonaemia | Experimental | Drug: ketoneKetone infusion. FDG-PET Scan. O2-PET scan. H2O-PET scan Muscle biopsy |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy
- BMI 20-30 kg/m2
Key exclusion criteria (5 listed)
- smoking
- alcohol abuse
- severe comorbidity
- blood donation 6 month prior
- claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketone3-OHB is infused intravenously. | Drug | Hyperketonaemia |
| placeboSaline infusion. | Drug | Control |
Primary outcome
Glucose metabolism in brain, CMR
Time frame: t=240-360 minutes
cerebral glucose metabolism measured by PET tracer during the above time frame
4 secondary outcomes
Stress metabolism
Time frame: 0-360 minutes
Oxygen use
Time frame: T=150-200 minutes
cerebral blood flow
Time frame: t=180-250 minutes
Intramuscular signaling
Time frame: t= 260 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
- Derived from this study: PubMed 33074729Lauritzen 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.
- Derived from this study: PubMed 30327354Lauritsen 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.
Related trials for Ketone Body Metabolism
Recruiting
Acute Effects of Ketone Monoester Co-ingestion With Dietary Protein on Whole-body Phenylalanine Oxidation, Phenylalanine Retention, and Myofibrillar Protein Breakdown Following Resistance Exercise in Young Males.
Post-exercise Period, Ketosis
Recruiting
Dietary Macronutrients and Gut Microbiota, Inflammation, and Metabolic Markers
Nutrition, Ketogenic Diet
Not yet recruiting
Acute Effects of Ketone Monoester Co-Ingestion With Dietary Protein on Whole-Body Phenylalanine Oxidation, Phenylalanine Retention, and Myofibrillar Protein Breakdown Following Resistance Exercise in Older Males
Ketosis, Resistance Exercise
Recruiting
Acute Effects of MCT Formulations on Beta-Hydroxybutyrate Response, Lipid Profile, and Glucose Levels in Healthy Adults
Ketone Body, Lipid Metabolism
Recruiting
Metabolic Effects of Medium-Chain Fatty Acids in Patients With Medium-Chain Acyl-CoA Dehydrogenase Deficiency and Healthy Individuals
Medium-chain Acyl-CoA Dehydrogenase Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mads Svart, MD principal investigator
Aarhus University / Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketone in people with Ketone Body Metabolism and Brain Metabolism, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose metabolism in brain, CMR (time frame: t=240-360 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02357550, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2016.