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

Investigating the Blood Glucose Lowering Effect of Exogenous Ketone Ingestion 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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Ketone supplement; Dietary supplement: Placebo supplement

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francis B Stephens, PhD; Phone Number: +44 1392722157; Email: f.b.stephens@exeter.ac.uk

Study Locations

• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, EX1 2LU
      • Recruiting
      • Sport & Health Sciences University of Exeter
      • Contact: Francis B Stephens, PhD; Phone Number: 2157 +441392 722157; Email: f.b.stephens@exeter.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketone supplementation; 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; 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 Comparator: Placebo; Placebo with stevia and bitter agent to flavour match	Dietary supplement: Placebo 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total rate of glucose appearance	Total rate of glucose appearance measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal	4 and 8 hours
Exogenous glucose rate of appearance	Exogenous rate of glucose appearance measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal	4 and 8 hours
Total rate of glucose disappearance	Total rate of glucose disappearance measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal	4 and 8 hours
Rate of gluconeogenesis	Rate of gluconeogenesis measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal	4 and 8 hours
Rate of glycogenolysis	Rate of glycogenolysis measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal	4 and 8 hours
Beta-cell function	Beta-cell function using dynamic modelling of insulin/c-peptide secretion over 4 and 8 hours following a meal	4 and 8 hours
Insulin concentration	Insulin concentration using ELISA assay over 4 and 8 hours following a meal	4 and 8 hours
Glucagon concentration	Glucagon concentration using ELISA assay over 4 and 8 hours following a meal	4 and 8 hours
GLP-1 concentration	GLP-1 using ELISA assay over 4 and 8 hours following a meal	4 and 8 hours
GIP concentration	GIP concentration using ELISA assay over 4 and 8 hours following a meal	4 and 8 hours
Glycerol concentration	Glycerol concentration using colorimetric assay over 4 and 8 hours following a meal	4 and 8 hours
Free fatty acid concentration	Free fatty acids using colorimetric assay over 4 and 8 hours following a meal	4 and 8 hours
Ketone concentration	Ketone concentration using colorimetric assay over 4 and 8 hours following a meal	4 and 8 hours
Energy expenditure	Energy expenditure using indirect calorimetry over 4 and 8 hours following a meal	4 and 8 hours

Collaborators and Investigators

• Sponsor: University of Exeter
• Collaborators: University of British Columbia; Medical Research Council
• Investigators: Principal Investigator: Francis B Stephens, PhD, University of Exeter

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 4765060

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No