NCT05238805

Brief Summary

The objective of this study is to make a comparison between 11C-acetate and 11C-Acetoacetate heart and kidney metabolism

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

January 4, 2022

Last Update Submit

January 16, 2023

Conditions

Ketoses, Metabolic

Keywords

ketonesheart metabolismkidney metabolism

Outcome Measures

Primary Outcomes (4)

  • Mean in left ventricule myocradial blood flow

    Heart acetate metabolism measured by TEP scan

    30 minutes

  • Mean in left ventricule myocardial blood flow

    Heart acetoacetate metabolism measured by TEP scan

    30 minutes

  • Mean in Kidney acetate uptake

    Kidney acetate uptake measured by TEP scan

    30 minutes

  • Mean in Kidney acetoacetate uptake

    Kidney acetoacetate uptake measured by TEP scan.

    30 minutes

Study Arms (1)

Observational heart and kidney metabolism

OTHER

Participants will have a PET scan with 11C-Acetate followed by a TEP Scan with 11C-Acetoacetate all in the same day.

Radiation: Observational heart and kidney on siemens TEP scan

Interventions

Observational heart and kidney on siemens TEP scanRADIATION

Same as arm description

Observational heart and kidney metabolism

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 55
  • BMI between 18,5 and 28
  • Healthy
  • Normal value for blood pressure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Center on Aging

Sherbrooke, Quebec, J1H 4C4, Canada

Location

MeSH Terms

Conditions

Ketosis

Condition Hierarchy (Ancestors)

AcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Participants will have to perform 2 scans one after the other
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2022

First Posted

February 14, 2022

Study Start

March 14, 2022

Primary Completion

August 14, 2022

Study Completion

August 14, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Locations

CA(1)