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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06324669
• Other study ID #: 4765060
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: March 2024
• Source: University of Exeter
• Contact: Francis B Stephens, PhD
• Phone: +44 1392722157
• Email: f.b.stephens[@]exeter.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 41 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Ketone supplement
100 mL flavoured drink containing 0.3 g/kg ketone monoester ((R)-3-hydroxybutyl (R)-3-hydroxybutyrate; ?G®, 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
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

Locations

Country	Name	City	State
United Kingdom	Sport & Health Sciences University of Exeter	Exeter	Devon

Sponsors (3)

Lead Sponsor	Collaborator
University of Exeter	Medical Research Council, University of British Columbia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Insulin concentration	Insulin concentration using ELISA assay over 4 and 8 hours following a meal	4 and 8 hours
Secondary	Glucagon concentration	Glucagon concentration using ELISA assay over 4 and 8 hours following a meal	4 and 8 hours
Secondary	GLP-1 concentration	GLP-1 using ELISA assay over 4 and 8 hours following a meal	4 and 8 hours
Secondary	GIP concentration	GIP concentration using ELISA assay over 4 and 8 hours following a meal	4 and 8 hours
Secondary	Glycerol concentration	Glycerol concentration using colorimetric assay over 4 and 8 hours following a meal	4 and 8 hours
Secondary	Free fatty acid concentration	Free fatty acids using colorimetric assay over 4 and 8 hours following a meal	4 and 8 hours
Secondary	Ketone concentration	Ketone concentration using colorimetric assay over 4 and 8 hours following a meal	4 and 8 hours
Secondary	Energy expenditure	Energy expenditure using indirect calorimetry over 4 and 8 hours following a meal	4 and 8 hours