Clinical trial NCT04194450: Exogenous Ketones in Type 2 Diabetes
Official title: The Effect of Acute Exogenous Oral Ketone Supplementation on Blood Glucose Levels in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketosis
Type 2 Diabetes
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma Glucose
timeFrame: 180 minutes
Secondary outcomes:
measure: Plasma Insulin
timeFrame: 180 minutes
measure: Plasma C-peptide
timeFrame: 180 minutes
measure: Plasma Free Fatty Acids
timeFrame: 180 minutes
measure: Plasma Tumour Necrosis Factor Alpha
timeFrame: 180 minutes
measure: Plasma Tumour Interleukin-1beta
timeFrame: 180 minutes
measure: Plasma Tumour Interleukin-6
timeFrame: 180 minutes
measure: Cerebral Blood Flow
timeFrame: 180 minutes
measure: Blood Pressure
timeFrame: 180 minutes
measure: Cognitive Function - Digital Symbol Substitution Task
timeFrame: 180 minutes
measure: Brain-derived Neurotrophic Factor
timeFrame: 180 minutes
measure: Number Blood Monocytes (x10^3 Cells/uL)
timeFrame: 180 minutes
measure: Self Reported Hunger and Fullness
timeFrame: 180 minutes
measure: Gastrointestinal Symptoms
timeFrame: 180 minutes
measure: Total Energy Consumed
timeFrame: 180 minutes after ketone or placebo ingestion
measure: Monocyte Histone Acetylation
timeFrame: 180 minutes
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia, Okanagan
state: British Columbia
Study officials:
References: