Type 2 Diabetes
Conditions
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.
Interventions
DIETARY_SUPPLEMENTKetone 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
DIETARY_SUPPLEMENTPlacebo 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
Sponsors
University of British Columbia
Medical Research Council
University of Exeter
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Coded, known only to independent individual
Intervention model description
Randomised cross over trial counterbalanced for trial order
Eligibility
Sex/Gender
ALL
Age
41 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Insulin concentration | 4 and 8 hours | Insulin concentration using ELISA assay 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 |
| GLP-1 concentration | 4 and 8 hours | GLP-1 using ELISA assay 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 |
| Free fatty acid concentration | 4 and 8 hours | Free fatty acids 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 |
| Glucagon concentration | 4 and 8 hours | Glucagon concentration using ELISA assay over 4 and 8 hours following a meal |
Countries
United Kingdom
Outcome results
None listed