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Ketone Esters in T2DM

NCT04854330 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-04-22

No results posted yet for this study

Summary

Type 2 diabetes mellitus (T2DM) reduces the ability of the body to use sugar as a fuel. As an alternative people with T2DM can use fat from the blood stream instead. Fat is a good store of energy, however, the body requires about 20% more oxygen to produce energy from fat compared to sugar. People with T2DM often have heart disease as well. This can lead to limited availability of oxygen in the heart muscle, which increases the workload of the heart and will impact on the ability to perform everyday tasks, such as walking up a flight of steps. Recently, it has been suggested that ketone esters (a sports drink that contains ketones) may be used as an alternative source of energy for people with diabetes as they are approximately 8% more efficient than fat. The investigators will assess whether these ketones can be used as a more efficient source of energy and improve how the heart works in people with T2DM. If successful, this is a relatively cheap treatment, which could be immediately implemented in people with T2DM to improve heart function and the ability to perform everyday tasks.

Conditions

Interventions

DIETARY_SUPPLEMENT

Ketone monoesters

A Kme commercially available supplement will be given to the participants in the form of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (ΔG®; TΔS Ltd, UK, Oxford, UK; 0.30 ml.kg-1 body mass) and will be ingested with water and cherry-flavoured stevia in a total volume of 100 ml.

DIETARY_SUPPLEMENT

Placebo

In the placebo condition, participants will consume 100 ml of water and cherry-flavoured stevia followed by the same 20 ml calorie-free sparkling spring water.

Sponsors & Collaborators

  • Portsmouth Hospitals NHS Trust

    collaborator OTHER_GOV

  • University of Portsmouth

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-26
Primary Completion
2023-02-21
Completion
2023-02-21

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04854330 on ClinicalTrials.gov