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Completed

NCT Number: NCT02357550

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

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.

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Key information

Conditions

Ketone Body Metabolism Brain Metabolism

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy
  • BMI 20-30 kg/m2

Exclusion criteria

  • smoking
  • alcohol abuse
  • severe comorbidity
  • blood donation 6 month prior
  • claustrophobia

Treatment and study plan

ketone

Drug

3-OHB is infused intravenously.

Placebo

Drug

Saline infusion.

Primary outcomes

  1. Glucose metabolism in brain, CMR

    Time frame: t=240-360 minutes

    cerebral glucose metabolism measured by PET tracer during the above time frame

Secondary outcomes

  1. Stress metabolism

    Time frame: 0-360 minutes

    growth hormone, cortisol, glucagon, adrenalin, ghrelin.

  2. Oxygen use

    Time frame: T=150-200 minutes

    cerebral oxygen consumption measured by PET tracer during the above time frame

  3. cerebral blood flow

    Time frame: t=180-250 minutes

    cerebral blood flow measured by PET tracer during the above time frame

  4. Intramuscular signaling

    Time frame: t= 260 minutes

    protein and insulin signaling in muscle

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 6, 2015
Registry last updated
Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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