Diabetes Mellitus, Ketosis
Conditions
Keywords
Diabetes, Exogenous ketones, Postprandial glycemia, Endogenous glucose production
Brief summary
What is the effect of a ketone drink on liver glucose production, and postprandial glycemia, in people with type 2 diabetes.
Detailed description
Background: Ketones are molecules that are naturally produced by our body during fasting or diets low in carbohydrates. Ketones can affect how our liver produces and maintains our body's blood sugar levels, which could be important in the management of type 2 diabetes (T2D), where high blood sugar levels are partly because of excess sugar production by the liver. Objectives: To determine if, and how, a ketone drink can lower blood glucose in people with T2D following a meal. Methods: Twelve people with T2D will visit our laboratory in the morning on two occasions and ingest a drink containing ketones or placebo on each visit in a random order before ingesting a milkshake style drink containing sugar. Blood samples will then be taken at regular intervals over 4 hours to determine if the ketone drink has lowered blood sugar levels in response to the meal, and if this was due to reduced sugar production by the liver. Value: This research will provide new knowledge about the regulation of liver blood sugar production in response to ketone ingestion. This may also inform future clinical trials to establish if ketone drinks could be used as a treatment for T2D.
Interventions
DIETARY_SUPPLEMENTKetone - beta-hydroxybutyrate (β-OHB)
Ketone - beta-hydroxybutyrate (β-OHB)
Sponsors
University of British Columbia
University of Exeter
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Intervention model description
Ketone vs placebo crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 2 diabetes by a physician, a current HbA1c of 6.5-8.5%, and receiving treatment with lifestyle advice or oral glucose-lowering medications. * Non-smoking * Blood pressure \<160/100 mm/Hg
Exclusion criteria
* Exogenous insulin or SGLT2 inhibitors for type 2 diabetes treatment. * Following a low-carbohydrate ketogenic diet, periodic fasting diet, or consuming ketogenic supplements. * Other diagnosed chronic metabolic, cardiovascular, respiratory, neurological, or gastrointestinal disease. * Smoker * Blood pressure \>160/100 mm/Hg * Lactose intolerant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EGP | 6 hours | Endogenous glucose production |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial glycemia | 4 hours | Postprandial glucose concentrations |
| Insulin | 6 hours | Serum insulin concentration |
| Plasma β-OHB | 6 hours | Plasma β-OHB concentrations |
Countries
United Kingdom
Outcome results
None listed