Acetoacetate and Acetate Metabolism in Patients With Chronic Kidney Failure.(RENO-TEP)

Sponsor
Université de Sherbrooke (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05968391
Collaborator
Nestle Health Science (Industry)
15
21

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: PET scan metabolic day

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
15 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Comparison of Acetoacetate and Acetate Kidney Uptake in Patients With Chronic Kidney Failure Measured by Positron Emission Tomography : the RENO-TEP Project
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Chronic kidney failure

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

Radiation: PET scan metabolic day
11C-Acetate and 11C-Acetoacetate PET scans

Outcome Measures

Primary Outcome Measures

  1. Mean in kidney acetate uptake [30 minutes]

    Kidney acetate uptake measured by pet scan

  2. Mean in kidney acetoacetate uptake [30 minutes]

    Kidney acetoacetate uptake measured by pet scan

  3. Mean in kidney acetoacetate metabolism [30 minutes]

    Kidney acetoacetate metabolism measured by pet scan

  4. Mean in kidney acetate metabolism [30 minutes]

    Kidney acetate metabolism measured by pet scan

Secondary Outcome Measures

  1. Mean in heart ejection fraction [30 minutes]

    Ejection fraction measured by pet scan

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Université de Sherbrooke
  • Nestle Health Science

Investigators

  • Principal Investigator: Mélanie Godin, MD, Université de Sherbrooke

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT05968391
Other Study ID Numbers:
  • 2024-5157
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Université de Sherbrooke
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2023