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

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Placebo supplement; Dietary Supplement: Ketone supplement

• Registration Number: NCT06324669
• Lead Sponsor: University of Exeter

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-12
• Study Start: 2024-03-16
• Study First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22
• Primary Completion: 2025-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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%

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo supplement	Placebo with stevia and bitter agent to flavour match
Ketone supplementation	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)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sport & Health Sciences University of Exeter; 🇬🇧 Exeter, Devon, United Kingdom