Exogenous Ketones in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

The Effect of Acute Exogenous Oral Ketone Supplementation on Blood Glucose Levels in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04194450
• Other study ID #: H19-02947
• Status: Completed
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: May 20, 2022

Study information

• Verified date: July 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Ketosis
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Ketone monoester
Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.
• Placebo
Acute ingestion of taste-matched placebo prior to assessment of outcomes.

Locations

Country	Name	City	State
Canada	University of British Columbia, Okanagan	Kelowna	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Glucose	Plasma glucose concentration after ketone or placebo ingestion	180 minutes
Secondary	Plasma Insulin	Insulin across concentration after ketone or placebo ingestion	180 minutes
Secondary	Plasma C-peptide	C-peptide across concentration after ketone or placebo ingestion	180 minutes
Secondary	Plasma Free Fatty Acids	Non-esterified fatty acid concentration after ketone or placebo ingestion	180 minutes
Secondary	Plasma Tumour Necrosis Factor Alpha	Plasma tumour necrosis factor alpha concentration after ketone or placebo ingestion	180 minutes
Secondary	Plasma Tumour Interleukin-1beta	Plasma tumour interleukin-1beta concentration after ketone or placebo ingestion	180 minutes
Secondary	Plasma Tumour Interleukin-6	Plasma tumour interleukin-6 concentration after ketone or placebo ingestion	180 minutes
Secondary	Cerebral Blood Flow	Intracranial blood flow velocity measured by ultrasound	180 minutes
Secondary	Blood Pressure	Blood pressure measured manually and by Finipres	180 minutes
Secondary	Cognitive Function	Measures of cognitive function using Brain Baseline battery on an iPad.	180 minutes
Secondary	Brain-derived Neurotrophic Factor	Brain-derived neurotrophic factor concentrations after ketone or placebo ingestion	180 minutes
Secondary	Blood Monocytes	Total blood monocytes and monocyte subsets after ketone or placebo ingestion	180 minutes
Secondary	Self Reported Hunger and Fullness	Self reported hunger and fullness by a 0 to 100 mm Visual Analog Scale (higher scores mean greater hunger or fullness)	180 minutes
Secondary	Gastrointestinal Symptoms	Gastrointestinal symptom questionnaire scores after ketone or placebo ingestion on a 0 to 100 mm Visual Analog Scale (higher scores mean greater symptoms)	180 minutes
Secondary	Total Energy Consumed	Total energy consumed in kilocalories in buffet style meal after ketone or placebo ingestion	180 minutes after ketone or placebo ingestion
Secondary	Monocyte Histone Acetylation	Histone acetylation status of monocytes measured after ketone or placebo ingestion	180 minutes