Exogenous Ketones in Type 2 Diabetes
The Effect of Acute Exogenous Oral Ketone Supplementation on Blood Glucose Levels in Type 2 Diabetes
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2019
CompletedFirst Posted
Study publicly available on registry
December 11, 2019
CompletedStudy Start
First participant enrolled
January 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2022
CompletedResults Posted
Study results publicly available
December 11, 2023
CompletedMay 30, 2025
May 1, 2025
2.3 years
December 9, 2019
March 14, 2023
May 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma Glucose
Plasma glucose concentration after ketone or placebo ingestion
180 minutes
Secondary Outcomes (15)
Plasma Insulin
180 minutes
Plasma C-peptide
180 minutes
Plasma Free Fatty Acids
180 minutes
Plasma Tumour Necrosis Factor Alpha
180 minutes
Plasma Tumour Interleukin-1beta
180 minutes
- +10 more secondary outcomes
Study Arms (2)
Ketone monoester
EXPERIMENTALAcute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)
Placebo
PLACEBO COMPARATORAcute dose of flavour-matched placebo.
Interventions
Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.
Acute ingestion of taste-matched placebo prior to assessment of outcomes.
Eligibility Criteria
You may qualify if:
- 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
- years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of British Columbia, Okanagan
Kelowna, British Columbia, V1V 1V7, Canada
Related Publications (1)
Baranowski BJ, Oliveira BF, Falkenhain K, Little JP, Mohammad A, Beaudette SM, Finch MS, Caldwell HG, Neudorf H, MacPherson REK, Walsh JJ. Effect of exogenous beta-hydroxybutyrate on BDNF signaling, cognition, and amyloid precursor protein processing in humans with T2D and insulin-resistant rodents. Am J Physiol Cell Physiol. 2025 Feb 1;328(2):C541-C556. doi: 10.1152/ajpcell.00867.2024. Epub 2025 Jan 13.
PMID: 39804761DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jonathan Little
- Organization
- University of British Columbia
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Placebo masked with flavouring and participants consume in opaque containers.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 9, 2019
First Posted
December 11, 2019
Study Start
January 15, 2020
Primary Completion
May 20, 2022
Study Completion
May 20, 2022
Last Updated
May 30, 2025
Results First Posted
December 11, 2023
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share