NCT05232812

Brief Summary

Ketone bodies are produced in the liver at high levels of fatty acids, and act as an important source of energy for the brain and heart during fasting. The energy production from ketone metabolism is less oxygen-demanding than both glucose and fatty acid metabolism, and ketone substances can therefore be a very energy-efficient substrate for the heart. Insulin-resistant people as well as people with heart disease have difficulty burning glucose in the heart due to the insulin resistant condition and are therefore dependent on other energy sources such as free fatty acids and ketones. Because ketones are oxygen-sparing compared to fatty acids, interventions that increase the level of ketone bodies can potentially reduce the heart's need for oxygen in patients with narrowed coronary arteries. PET/CT is a functional and non-invasive imaging modality and suitable for tracking the fate of metabolites non-invasively, as most substrates or metabolites can be labeled by a PET isotope. The purpose of this experiment is therefore to validate a new ketone tracer called 3-\[11C\]-OHB. Implementation of the 3-\[11C\]-OHB tracer will in future allow the investigators to more directly estimate the impact of different levels of ketone bodies on organ functions by measuring tissue-specific ketone uptake, both after intravenous and oral administration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable diabetes-mellitus-type-2

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 10, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2023

Completed
Last Updated

March 31, 2023

Status Verified

January 1, 2023

Enrollment Period

10 months

First QC Date

January 10, 2022

Last Update Submit

March 30, 2023

Conditions

Diabetes Mellitus, Type 2Heart FailureHealthy

Keywords

Ketone bodiesWhole-body biodistribution

Outcome Measures

Primary Outcomes (2)

  • Biodistribution of 3-[11C]-OHB

    The investigators will measure time activity curves by quantifying uptake of the PET ketone tracer 3-\[11C\]-OHB in kilo becquerel/ml over time (seconds).

    Through study completion, an average of 6 months

  • Radiation exposure of 3-[11C]-OHB

    The investigators will measure radiation exposure of 3-\[11C\]-OHB in millisievert in relevant organs.

    Through study completion, an average of 6 months

Study Arms (1)

Administration of 3-[11C]-OHB

EXPERIMENTAL

All participants will first be injected with 200 MBq 3-\[11C\]-OHB followed by an oral ingestion of 100 MBq 3-\[11C\]-OHB.

Radiation: 3-[11C]-OHB

Interventions

3-[11C]-OHBRADIATION

The PET tracer 3-\[11C\]-OHB is used to quantify 3-hydroxybutyrate uptake

Administration of 3-[11C]-OHB

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 50-70 years
  • BMI: 20-30 kg/m\^2

You may not qualify if:

  • All drugs that could affect the outcome
  • HbA1c \> 48 mmol/mol
  • Known heart failure og episodes of acute myocardial infarction
  • Liver disease ALAT \> higher than 3 times of the normal level
  • Kidney disease eGFR \< 60 ml/min
  • Participation in other studies with radiation in the last 6 months
  • Alcohol addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus N, Jutland, 8200, Denmark

Location

Related Publications (1)

  • Luong TV, Nielsen EN, Falborg L, Kjaerulff MLG, Tolbod LP, Sondergaard E, Moller N, Munk OL, Gormsen LC. Intravenous and oral whole body ketone dosimetry, biodistribution, metabolite correction and kinetics studied by (R)-[1-11C]beta-hydroxybutyrate ([11C]OHB) PET in healthy humans. EJNMMI Radiopharm Chem. 2023 Jun 14;8(1):12. doi: 10.1186/s41181-023-00198-z.

    PMID: 37314530DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Heart Failure

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2022

First Posted

February 10, 2022

Study Start

June 1, 2022

Primary Completion

March 29, 2023

Study Completion

March 29, 2023

Last Updated

March 31, 2023

Record last verified: 2023-01

Locations

DK(1)