Exogenous Ketones in Type 2 Diabetes (NCT04194450) | Clinical Trial Compass
CompletedNot Applicable
Exogenous Ketones in Type 2 Diabetes
Canada19 participantsStarted 2020-01-15
Plain-language 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.
Who can participate
Age range
20 Years – 69 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.