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OpenTrials
Completed

NCT Number: NCT05518448

The Effect of a Ketone Drink on Liver Glucose Production in People With Type 2 Diabetes

What is the effect of a ketone drink on liver glucose production, and postprandial glycemia, in people with type 2 diabetes.

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sport & Health Sciences, University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

About this study

Background: Ketones are molecules that are naturally produced by our body during fasting or diets low in carbohydrates. Ketones can affect how our liver produces and maintains our body's blood sugar levels, which could be important in the management of type 2 diabetes (T2D), where high blood sugar levels are partly because of excess sugar production by the liver.

Objectives: To determine if, and how, a ketone drink can lower blood glucose in people with T2D following a meal.

Methods: Twelve people with T2D will visit our laboratory in the morning on two occasions and ingest a drink containing ketones or placebo on each visit in a random order before ingesting a milkshake style drink containing sugar. Blood samples will then be taken at regular intervals over 4 hours to determine if the ketone drink has lowered blood sugar levels in response to the meal, and if this was due to reduced sugar production by the liver.

Value: This research will provide new knowledge about the regulation of liver blood sugar production in response to ketone ingestion. This may also inform future clinical trials to establish if ketone drinks could be used as a treatment for T2D.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with type 2 diabetes by a physician, a current HbA1c of 6.5-8.5%, and receiving treatment with lifestyle advice or oral glucose-lowering medications.
  • Non-smoking
  • Blood pressure <160/100 mm/Hg

Exclusion criteria

  • Exogenous insulin or SGLT2 inhibitors for type 2 diabetes treatment.
  • Following a low-carbohydrate ketogenic diet, periodic fasting diet, or consuming ketogenic supplements.
  • Other diagnosed chronic metabolic, cardiovascular, respiratory, neurological, or gastrointestinal disease.
  • Smoker
  • Blood pressure >160/100 mm/Hg
  • Lactose intolerant

Treatment and study plan

Ketone - beta-hydroxybutyrate (β-OHB)

Dietary Supplement

Ketone - beta-hydroxybutyrate (β-OHB)

Primary outcomes

  1. EGP

    Time frame: 6 hours

    Endogenous glucose production

Secondary outcomes

  1. Postprandial glycemia

    Time frame: 4 hours

    Postprandial glucose concentrations

  2. Insulin

    Time frame: 6 hours

    Serum insulin concentration

  3. Plasma β-OHB

    Time frame: 6 hours

    Plasma β-OHB concentrations

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • University of British Columbia

Registry information

Acronym: KES2

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 26, 2022
Registry last updated
May 21, 2024

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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