Ketoses, MetabolicNCT05238805
Double Pet Project : A Comparison Between 11C-Acetate and 11C-acetoacetate Heart and Kidney Uptake
A study testing Observational heart and kidney on siemens TEP scan in people with Ketoses, Metabolic, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The objective of this study is to make a comparison between 11C-acetate and 11C-Acetoacetate heart and kidney metabolism Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketoses, Metabolic
- What is being tested?
- Observational heart and kidney on siemens TEP scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 14 Mar 2022to 14 Aug 2022
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 55
- BMI between 18,5 and 28
- Healthy
- Normal value for blood pressure
Who cannot join
- Taking drugs that could influence metabolism
- Diabetes or prediabetes
- Pregnancy or lactation
- Participation in a intensive sport program
- Being on a ketogenic diet
- Any clinical abnomally in prescreen blood sample
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Pet Project : A Comparison Between 11C-Acetate and 11C-acetoacetate Heart and
The objective of this study is to make a comparison between 11C-acetate and 11C-Acetoacetate heart and kidney metabolism
Read the detailed description
Healthy people will have two positron emission tomography scan to perform. One, with a 11C-Acetate Tracer and the other with 11C-Acetoacetate. The results will allow to determine if both tracers are used in a similar way but the organs and see if the investigators can use the already validated analyse method for acetate to make acetoacetate analysis
- Conditions
- Ketoses, Metabolic
- Being tested
- Observational heart and kidney on siemens TEP scan
- Keywords
- ketones, heart metabolism, kidney metabolism
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational heart and kidney on siemens TEP scanRadiation
Same as arm description
| Study group | Role | What they receive |
|---|---|---|
| Observational heart and kidney metabolism | Other | Participants will have a PET scan with 11C-Acetate followed by a TEP Scan with 11C-Acetoacetate all in the same day. Receives: Radiation: Observational heart and kidney on siemens TEP scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean in left ventricule myocradial blood flow
Heart acetate metabolism measured by TEP scan
Measured: 30 minutes
Mean in left ventricule myocardial blood flow
Heart acetoacetate metabolism measured by TEP scan
Measured: 30 minutes
Mean in Kidney acetate uptake
Kidney acetate uptake measured by TEP scan
Measured: 30 minutes
Mean in Kidney acetoacetate uptake
Kidney acetoacetate uptake measured by TEP scan.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start14 Mar 2022
- Primary completion14 Aug 2022
- Study completion14 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ketoses, MetabolicStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Participants will have to perform 2 scans one after the other
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Nestlé Health Science Spain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238805
- Sponsor's protocol ID
- 2022-4540
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Pet Project : A Comparison Between 11C-Acetate and 11C-acetoacetate Heart and
- ClinicalTrials.gov ID
- NCT05238805
- Acronym / sponsor ID
- 2022-4540
- Conditions
- Ketoses, Metabolic
- Keywords
- ketones, heart metabolism, kidney metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Nestlé Health Science Spain
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 14 Aug 2022 (actual)
- Study completion
- 14 Aug 2022 (actual)
- First posted
- 14 Feb 2022 (actual)
- 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.
The objective of this study is to make a comparison between 11C-acetate and 11C-Acetoacetate heart and kidney metabolism
Detailed description
Healthy people will have two positron emission tomography scan to perform. One, with a 11C-Acetate Tracer and the other with 11C-Acetoacetate. The results will allow to determine if both tracers are used in a similar way but the organs and see if the investigators can use the already validated analyse method for acetate to make acetoacetate analysis
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will have to perform 2 scans one after the other
| Arm | Type | Receives |
|---|---|---|
| Observational heart and kidney metabolism | Other | Radiation: Observational heart and kidney on siemens TEP scanParticipants will have a PET scan with 11C-Acetate followed by a TEP Scan with 11C-Acetoacetate all in the same day. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged between 18 and 55
- BMI between 18,5 and 28
- Healthy
- Normal value for blood pressure
Key exclusion criteria (6 listed)
- Taking drugs that could influence metabolism
- Diabetes or prediabetes
- Pregnancy or lactation
- Participation in a intensive sport program
- Being on a ketogenic diet
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 |
|---|---|---|
| Observational heart and kidney on siemens TEP scanSame as arm description | Radiation | Observational heart and kidney metabolism |
Primary outcome
Mean in left ventricule myocradial blood flow
Time frame: 30 minutes
Heart acetate metabolism measured by TEP scan
Mean in left ventricule myocardial blood flow
Time frame: 30 minutes
Heart acetoacetate metabolism measured by TEP scan
Mean in Kidney acetate uptake
Time frame: 30 minutes
Kidney acetate uptake measured by TEP scan
Mean in Kidney acetoacetate uptake
Time frame: 30 minutes
Kidney acetoacetate uptake measured by TEP scan.
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 2023.
Related trials for Ketoses, Metabolic
Active, not recruitingPhase 2/3
Effect of Nutritional Ketosis on Alcohol Metabolism
Ketoses, Metabolic, Ketogenic Dieting
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Observational heart and kidney on siemens TEP scan in people with Ketoses, Metabolic, run by Université de Sherbrooke at 1 site in Canada.
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 4 inclusion and 6 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 2023. 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 Canada. 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. 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?
Mean in left ventricule myocradial blood flow (time frame: 30 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2023.