Recruiting

Acetoacetate & Acetate

Sponsor:

Université de Sherbrooke

Code:

NCT05968391

Conditions

Kidney Failure, Chronic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PET scan metabolic day

Study Details

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.

Conditions

Kidney Failure, Chronic

Study ID

NCT05968391

Start date

Feb 2, 2024

Status verified date

May, 2024

Completion date

Jun 15, 2025

Anticipated

Primary completion date

Dec 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

Chronic kidney failure

No interventions for the purpose of the study. They will simply undergo two PET scans consecutively

Interventions

PET scan metabolic day

11C-Acetate and 11C-Acetoacetate PET scans

Primary outcome measure

  • Mean in kidney acetate uptake [ Time Frame: 30 minutes ]
  • Mean in kidney acetoacetate uptake [ Time Frame: 30 minutes ]
  • Mean in kidney acetoacetate metabolism [ Time Frame: 30 minutes ]
  • Mean in kidney acetate metabolism [ Time Frame: 30 minutes ]

Central Contacts and Locations

Central contacts

Locations

Centre de recherche sur le vieillissement

Recruiting

Sherbrooke, Quebec, Canada, J1H 4C4

Contacts

More Information

Sponsor

Université de Sherbrooke

Last update posted

Jun 3, 2024

Last verified

May, 2024

Keywords

  • ketone
  • acetoacetate
  • acetate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2024-06-03.