Type 2 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants will visit the laboratory for baseline screening to assess their eligibility. Thereafter they will undergo 2 trials, with trial order (ketone or placebo) randomised using excel ‘rand’ fun
?G®, University of Oxford
https://www.deltagketones.com) or maltodextrin placebo with stevia and bitter agent to flavour match. The ketone ester is commercially available, is not contraindicated for diabetes medication, the do
Sponsors
University of Exeter
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 |
|---|---|
| Rate of endogenous glucose production over 4 hours in response to a meal measured by blood sample | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total rate of glucose appearance measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal 2. Exogenous rate of glucose appearance measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal 3. Total rate of glucose disappearance measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal 4. Rate of gluconeogenesis measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal 5. Rate of glycogenolysis measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal 6. Beta-cell function using dynamic modelling of insulin/c-peptide secretion over 4 and 8 hours following a meal 7. Insulin concentration using ELISA assay over 4 and 8 hours following a meal 8. glucagon concentration using ELISA assay over 4 and 8 hours following a meal 9. GLP-1 using ELISA assay over 4 and 8 hours following a meal 10. GIP concentration using ELISA assay over 4 and 8 hours following a meal 11. Glycerol concentration using colorimetric assay over 4 and 8 hours following a meal 12. Free fatty acids using colorimetric assay over 4 and 8 hours following a meal 13. Ketone concentration using colorimetric assay over 4 and 8 hours following a meal 13. Energy expenditure using indirect calorimetry over 4 and 8 hours following a meal | — |
Countries
England, United Kingdom
Contacts
Public ContactFrancis;George Stephens;Pavis
;
Outcome results
None listed