N/A
N=19
Exogenous Ketones in Type 2 Diabetes
Ketosis · Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04194450 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Plasma Glucose — 7.3; 7.2; 6.2; 6.6 mmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ketone monoester (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- University of British Columbia
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Glucose |
7.3; 7.2; 6.2; 6.6; 6.3; 6.2 | — |
| SECONDARY Plasma Insulin |
26.7; 28.2; 24.3; 21.4 | — |
| SECONDARY Plasma C-peptide |
4,384; 4,438; 3,908; 3,918 | — |
| SECONDARY Plasma Free Fatty Acids |
0.42; 0.40; 0.18; 0.43 | — |
| SECONDARY Plasma Tumour Necrosis Factor Alpha |
1.1; 1.2; 1.0; 1.1 | — |
| SECONDARY Plasma Tumour Interleukin-1beta |
253; 115; 106; 102 | — |
| SECONDARY Plasma Tumour Interleukin-6 |
1.5; 2.7; 2.7; 2.7 | — |
| SECONDARY Cerebral Blood Flow |
— | — |
| SECONDARY Blood Pressure |
133; 130; 139; 136; 79; 77 | — |
| SECONDARY Cognitive Function - Digital Symbol Substitution Task |
32.8; 32.4; 35.7; 34.5 | — |
| SECONDARY Brain-derived Neurotrophic Factor |
7.1; 5.5; 4.8; 5.7 | — |
| SECONDARY Number Blood Monocytes (x10^3 Cells/uL) |
408; 442; 445; 447 | — |
| SECONDARY Self Reported Hunger and Fullness |
46; 42; 58; 60 | — |
| SECONDARY Gastrointestinal Symptoms |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Total Energy Consumed |
823; 948 | — |
| SECONDARY Monocyte Histone Acetylation |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT04194450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.