Back to resultsDouble Pet Project : A Comparison Between 11C-Acetate and 11C-acetoacetate Heart and Kidney Uptake
Primary Purpose
Ketoses, Metabolic
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Observational heart and kidney on siemens TEP scan
Sponsored by
About this trial
This is an interventional health services research trial for Ketoses, Metabolic focused on measuring ketones, heart metabolism, kidney metabolism
Eligibility Criteria
Inclusion Criteria:
- Aged between 18 and 55
- BMI between 18,5 and 28
- Healthy
- Normal value for blood pressure
Exclusion Criteria:
- 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
Sites / Locations
- Research Center on Aging
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Observational heart and kidney metabolism
Arm Description
Participants will have a PET scan with 11C-Acetate followed by a TEP Scan with 11C-Acetoacetate all in the same day.
Outcomes
Primary Outcome Measures
Mean in left ventricule myocradial blood flow
Heart acetate metabolism measured by TEP scan
Mean in left ventricule myocardial blood flow
Heart acetoacetate metabolism measured by TEP scan
Mean in Kidney acetate uptake
Kidney acetate uptake measured by TEP scan
Mean in Kidney acetoacetate uptake
Kidney acetoacetate uptake measured by TEP scan.
Secondary Outcome Measures
Full Information
NCT ID
NCT05238805
First Posted
January 4, 2022
Last Updated
January 16, 2023
Sponsor
Université de Sherbrooke
Collaborators
Nestlé Health Science Spain
1. Study Identification
Unique Protocol Identification Number
NCT05238805
Brief Title
Double Pet Project : A Comparison Between 11C-Acetate and 11C-acetoacetate Heart and Kidney Uptake
Official Title
Double Pet Project : A Comparison Between 11C-Acetate and 11C-acetoacetate Heart and
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
August 14, 2022 (Actual)
Study Completion Date
August 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke
Collaborators
Nestlé Health Science Spain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketoses, Metabolic
Keywords
ketones, heart metabolism, kidney metabolism
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Participants will have to perform 2 scans one after the other
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Observational heart and kidney metabolism
Arm Type
Other
Arm Description
Participants will have a PET scan with 11C-Acetate followed by a TEP Scan with 11C-Acetoacetate all in the same day.
Intervention Type
Radiation
Intervention Name(s)
Observational heart and kidney on siemens TEP scan
Intervention Description
Same as arm description
Primary Outcome Measure Information:
Title
Mean in left ventricule myocradial blood flow
Description
Heart acetate metabolism measured by TEP scan
Time Frame
30 minutes
Title
Mean in left ventricule myocardial blood flow
Description
Heart acetoacetate metabolism measured by TEP scan
Time Frame
30 minutes
Title
Mean in Kidney acetate uptake
Description
Kidney acetate uptake measured by TEP scan
Time Frame
30 minutes
Title
Mean in Kidney acetoacetate uptake
Description
Kidney acetoacetate uptake measured by TEP scan.
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged between 18 and 55
BMI between 18,5 and 28
Healthy
Normal value for blood pressure
Exclusion Criteria:
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
Facility Information:
Facility Name
Research Center on Aging
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4C4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Double Pet Project : A Comparison Between 11C-Acetate and 11C-acetoacetate Heart and Kidney Uptake
We'll reach out to this number within 24 hrs