Exogenous Ketones in Type 2 Diabetes

University of British Columbia

Status: Completed

Conditions: Ketosis; Type 2 Diabetes

Treatments: Dietary Supplement: Ketone monoester; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04194450

H19-02947

Details and patient eligibility

About

Exogenous ketone supplements are proposed to have glucose-lowering potential, provide an alternative fuel for the brain and to enhance cognitive function. No studies have tested whether exogenous ketones can lower blood glucose in people with type 2 diabetes. In addition, the impact of exogenous ketones on brain blood flow, cognitive function or brain-derived neurotrophic factor in humans is unknown. The purpose of this study is to determine if acutely ingesting exogenous ketones, in the form of a ketone monoester drink, can lower glucose and improve measures of brain/cognitive function in humans with type 2 diabetes. Participants will consume a ketone monoester drink or placebo with blood samples, brain blood flow, and cognitive function assessed over 180 minutes. The researchers will also test how the ketone monoester drink impacts appetite and measures of inflammation.

Enrollment: 19 patients

Sex: All

Ages: 20 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• physician-diagnosed type 2 diabetes of ≥1 year
• current hemoglobin A1C (HbA1c) of 6.5-8.0%
• treatment with lifestyle or stable (≥3 months) oral glucose-lowering medications
• blood pressure of <160/99 mm Hg assessed according to guidelines
• non-smoking
• no prior history of cardiovascular disease or stroke
• not on hormone replacement therapy, corticosteroids, or anti-inflammatory medications
• 20-75 years old

Exclusion criteria

• being a competitive endurance athlete
• taking exogenous insulin or sodium glucose transporter 2 (SGLT2) inhibitors
• following a ketogenic diet, low-calorie diet, periodic fasting regimen, or consume ketogenic supplements
• being unable to travel to and from the university
• being unable to follow the controlled diet instructions
• being pregnant or planning to become pregnant during the study (if female)
• disorders of fat metabolism, chronic pancreatitis, had gastric bypass surgery and/or gallbladder disease
• being unable to read or communicate in English

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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19 participants in 2 patient groups, including a placebo group

Ketone monoester

Experimental group

Description:

Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)

Treatment:

Dietary Supplement: Ketone monoester

Placebo

Placebo Comparator group

Description:

Acute dose of flavour-matched placebo.

Treatment:

Dietary Supplement: Placebo