Clinical trial NCT05968391: Acetoacetate and Acetate Metabolism in Patients With Chronic Kidney Failure.(RENO-TEP)
Official title: Comparison of Acetoacetate and Acetate Kidney Uptake in Patients With Chronic Kidney Failure Measured by Positron Emission Tomography : the RENO-TEP Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Failure, Chronic
Keywords: ketone
acetoacetate
acetate
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Nestle Health Science
First posted: 2023-08-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with kidney failure

Brief summary: The objective of this study is to nake a comparison between 11c-acetate and 11c-acetoacetate kidney uptake in chronic kidney failure patients.

Detailed description: Chronic kidney failure patients will be ask to perform two positron emission tomography scan during the same day. One, with a 11C-Acetate Tracer and the other with 11C-Acetoacetate. The results will allow to determine the difference between the two tracers and will ultimately be compared with precedent results of healthy controls.

Eligibility criteria: Inclusion Criteria:

* BMI between 18.5 and 40
* Kidney failure if GFR betweem 30 and 60 mL/min/1.73m2
* Stable medication for at least 4 weeks

Exclusion Criteria:

1. Receive cytotoxic therapy for primary or secondary kidney disease within 6 months prior to enrollment
2. Organ Transplant History
3. Class IV congestive heart failure (New York Heart Association)
4. Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrollment
5. Coronary revascularization (percutaneous coronary intervention or arterial bypass) or valve repair/replacement within 12 weeks of enrollment or is scheduled to undergo one of these procedures within 4 weeks of enrollment
6. Any condition outside the realm of renal and cardiovascular disease, such as, but not limited to, malignancy, with a life expectancy of less than 2 years in the clinical judgment of the investigator
7. Active malignancy requiring treatment at Visit 1 (except successfully treated basal or squamous cell carcinoma).
8. Hepatic impairment (aspartate transaminase or alanine transaminase \>3x upper limit of normal; or total bilirubin \>2x upper limit of normal at time of enrollment
9. Pregnancy or lactation
10. Adherence to a ketogenic diet, consumption of ketogenic products or supplements or intermittent fasting or other diet or supplements that may significantly increase ketones in the past two months.
11. Daily alcohol consumption \>2 servings per day
12. Participation in other interventional research projects concurrently or participation in other PET research projects in the last year, which exceeds the recommended limits
13. Inability to lie still in supine position;
14. Medical fluid restriction limiting fluid intake for the procedure

Primary outcomes:
measure: Mean in kidney acetate uptake
timeFrame: 30 minutes
measure: Mean in kidney acetoacetate uptake
timeFrame: 30 minutes
measure: Mean in kidney acetoacetate metabolism
timeFrame: 30 minutes
measure: Mean in kidney acetate metabolism
timeFrame: 30 minutes
Secondary outcomes:
measure: Mean in heart ejection fraction
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche sur le vieillissement
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Mélanie Godin, MD
role: PRINCIPAL_INVESTIGATOR
References: