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Completed

NCT Number: NCT06324669

The Effect of a Ketone Drink on Blood Glucose Levels in People With Type 2 Diabetes

Ketones are naturally produced by our body and can affect our blood sugar levels. Ketones could be important in the treatment of type 2 diabetes (T2D). The purpose of this research is to determine if a ketone drink can lower blood sugar in people with T2D following a meal. This research will provide new knowledge about the regulation of blood sugar. This may also inform if ketone drinks could be used as a treatment for T2D.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

41 year–70 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 41-70 years old
  • Body mass index 27-40 mg/m²
  • Type 2 diagnosis for more than 1 year
  • HbA1c >6%

Exclusion criteria

  • Currently following ketogenic diet
  • Use of insulin
  • HbA1c >10%
  • Recent weight loss (>5kg in 6 months)
  • Recent eGFR <30mL/min
  • Heart failure
  • Substance abuse
  • Cancer
  • Myocardial infarction within 6 months
  • Pregnancy or consideration of
  • Use of antipsychotic drugs

Treatment and study plan

Ketone Supplement

Dietary Supplement

100 mL flavoured drink containing 0.3 g/kg ketone monoester ((R)-3-hydroxybutyl (R)-3-hydroxybutyrate; ΔG®, University of Oxford; https://www.deltagketones.com) consumed 30 min prior to a mixed meal tolerance test, on 2 occasions during test day

Placebo supplement

Dietary Supplement

Placebo with stevia and bitter agent to flavour match, consumed 30 min prior to a mixed meal tolerance test, on 2 occasions during test day

Primary outcomes

  1. Rate of endogenous glucose production

    Time frame: 4 hours

    Rate of endogenous glucose production over 4 hours in response to a meal measured by blood sample

Secondary outcomes

  1. Total rate of glucose appearance

    Time frame: 4 and 8 hours

    Total rate of glucose appearance measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal

  2. Exogenous glucose rate of appearance

    Time frame: 4 and 8 hours

    Exogenous rate of glucose appearance measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal

  3. Total rate of glucose disappearance

    Time frame: 4 and 8 hours

    Total rate of glucose disappearance measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal

  4. Rate of gluconeogenesis

    Time frame: 4 and 8 hours

    Rate of gluconeogenesis measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal

  5. Rate of glycogenolysis

    Time frame: 4 and 8 hours

    Rate of glycogenolysis measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal

  6. Beta-cell function

    Time frame: 4 and 8 hours

    Beta-cell function using dynamic modelling of insulin/c-peptide secretion over 4 and 8 hours following a meal

  7. Insulin concentration

    Time frame: 4 and 8 hours

    Insulin concentration using ELISA assay over 4 and 8 hours following a meal

  8. Glucagon concentration

    Time frame: 4 and 8 hours

    Glucagon concentration using ELISA assay over 4 and 8 hours following a meal

  9. GLP-1 concentration

    Time frame: 4 and 8 hours

    GLP-1 using ELISA assay over 4 and 8 hours following a meal

  10. GIP concentration

    Time frame: 4 and 8 hours

    GIP concentration using ELISA assay over 4 and 8 hours following a meal

  11. Glycerol concentration

    Time frame: 4 and 8 hours

    Glycerol concentration using colorimetric assay over 4 and 8 hours following a meal

  12. Free fatty acid concentration

    Time frame: 4 and 8 hours

    Free fatty acids using colorimetric assay over 4 and 8 hours following a meal

  13. Ketone concentration

    Time frame: 4 and 8 hours

    Ketone concentration using colorimetric assay over 4 and 8 hours following a meal

  14. Energy expenditure

    Time frame: 4 and 8 hours

    Energy expenditure using indirect calorimetry over 4 and 8 hours following a meal

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • Medical Research Council
  • University of British Columbia

Registry information

Official study title

Investigating the Blood Glucose Lowering Effect of Exogenous Ketone Ingestion in People With Type 2 Diabetes

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 22, 2024
Registry last updated
Apr 18, 2025

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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