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

NCT06324669 | Completed

• 1 other identifier: 4765060
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Rate of endogenous glucose production

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

  4 hours

Secondary Outcomes (14)

• Total rate of glucose appearance

  4 and 8 hours

• Exogenous glucose rate of appearance

  4 and 8 hours

• Total rate of glucose disappearance

  4 and 8 hours

• Rate of gluconeogenesis

  4 and 8 hours

• Rate of glycogenolysis

  4 and 8 hours

Study Arms (2)

Ketone supplementation

EXPERIMENTAL

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)

Dietary Supplement: Ketone supplement

Placebo

PLACEBO COMPARATOR

Placebo with stevia and bitter agent to flavour match

Dietary Supplement: Placebo supplement

Interventions

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

Ketone supplementation

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

Placebo

Eligibility Criteria

• Age: 41 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead
• University of British Columbia: collaborator
• Medical Research Council: collaborator

Study Sites (1)

Sport & Health Sciences University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Francis B Stephens, PhD

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Coded, known only to independent individual
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised cross over trial counterbalanced for trial order

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 22, 2024
• Study Start: March 16, 2024
• Primary Completion: January 26, 2025
• Study Completion: January 26, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

GB (1)