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

NCT05968391 | Recruiting

• 1 other identifier: 2024-5157
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

ketone; acetoacetate; acetate

Outcome Measures

Primary Outcomes (4)

• Mean in kidney acetate uptake

  Kidney acetate uptake measured by pet scan

  30 minutes

• Mean in kidney acetoacetate uptake

  Kidney acetoacetate uptake measured by pet scan

  30 minutes

• Mean in kidney acetoacetate metabolism

  Kidney acetoacetate metabolism measured by pet scan

  30 minutes

• Mean in kidney acetate metabolism

  Kidney acetate metabolism measured by pet scan

  30 minutes

Secondary Outcomes (1)

• Mean in heart ejection fraction

  30 minutes

Study Arms (1)

Chronic kidney failure

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

Radiation: PET scan metabolic day

Interventions

PET scan metabolic day RADIATION

11C-Acetate and 11C-Acetoacetate PET scans

Chronic kidney failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People with kidney failure

You may qualify if:

• 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

You may not qualify if:

• Receive cytotoxic therapy for primary or secondary kidney disease within 6 months prior to enrollment
• Organ Transplant History
• Class IV congestive heart failure (New York Heart Association)
• Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrollment
• 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
• 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
• Active malignancy requiring treatment at Visit 1 (except successfully treated basal or squamous cell carcinoma).
• Hepatic impairment (aspartate transaminase or alanine transaminase \>3x upper limit of normal; or total bilirubin \>2x upper limit of normal at time of enrollment
• Pregnancy or lactation
• 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.
• Daily alcohol consumption \>2 servings per day
• Participation in other interventional research projects concurrently or participation in other PET research projects in the last year, which exceeds the recommended limits
• Inability to lie still in supine position;
• Medical fluid restriction limiting fluid intake for the procedure

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Nestle Health Science: collaborator

Study Sites (1)

Centre de recherche sur le vieillissement

Sherbrooke, Quebec, J1H 4C4, Canada

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Ketosis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mélanie Godin, MD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie St-Pierre, MSc

CONTACT

8197802220; valerie.R.st-pierre@usherbrooke.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 1, 2023
• Study Start: February 2, 2024
• Primary Completion: December 15, 2024
• Study Completion: June 15, 2025
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)