Ketones Influence on Glucose Metabolism in Brain. A Human Positron Emission Tomography (PET) Study

NCT ID: NCT02357550

Last Updated: 2016-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-01-31

Brief Summary

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This project tend to investigate the affection of ketone bodies on brain metabolism. This will be done by measuring human cerebral uptake of energy substrates, together with functional parameters, using PET imaging and appropriate radiotracers under hyperketonemia in healthy subjects by ketone infusion.

Hypotheses

1. Increased levels of ketone bodies in healthy subjects leads to decreased glucose uptake by brain cells contributing to hyperglycaemia.
2. Increased levels of ketone bodies in healthy subjects leads to increased cerebral blood flow.
3. Altered oxygen consumption during hyperketonemia in healthy subjects.

Detailed Description

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Conditions

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Ketone Body Metabolism Brain Metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Saline infusion. FDG-PET Scan. O2-PET scan. H2O-PET scan Muscle biopsy

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Saline infusion.

Hyperketonaemia

Ketone infusion. FDG-PET Scan. O2-PET scan. H2O-PET scan Muscle biopsy

Group Type EXPERIMENTAL

ketone

Intervention Type DRUG

3-OHB is infused intravenously.

Interventions

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ketone

3-OHB is infused intravenously.

Intervention Type DRUG

placebo

Saline infusion.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy
* BMI 20-30 kg/m2

Exclusion Criteria

* smoking
* alcohol abuse
* severe comorbidity
* blood donation 6 month prior
* claustrophobia
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mads Svart, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University / Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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Lauritzen ES, Svart MV, Voss T, Moller N, Bjerre M. Impact of Acutely Increased Endogenous- and Exogenous Ketone Bodies on FGF21 Levels in Humans. Endocr Res. 2021 Feb;46(1):20-27. doi: 10.1080/07435800.2020.1831015. Epub 2020 Oct 19.

Reference Type DERIVED
PMID: 33074729 (View on PubMed)

Lauritsen KM, Sondergaard E, Svart M, Moller N, Gormsen LC. Ketone Body Infusion Increases Circulating Erythropoietin and Bone Marrow Glucose Uptake. Diabetes Care. 2018 Dec;41(12):e152-e154. doi: 10.2337/dc18-1421. Epub 2018 Oct 16. No abstract available.

Reference Type DERIVED
PMID: 30327354 (View on PubMed)

Other Identifiers

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RM-1-10-72-106-14

Identifier Type: -

Identifier Source: org_study_id

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