The Effect of a Ketone Drink on Liver Glucose Production in People With Type 2 Diabetes
KES2
1 other identifier
interventional
10
1 country
1
Brief Summary
What is the effect of a ketone drink on liver glucose production, and postprandial glycemia, in people with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 3, 2022
CompletedFirst Submitted
Initial submission to the registry
August 24, 2022
CompletedFirst Posted
Study publicly available on registry
August 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedMay 21, 2024
May 1, 2024
7 months
August 24, 2022
May 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
EGP
Endogenous glucose production
6 hours
Secondary Outcomes (3)
Postprandial glycemia
4 hours
Insulin
6 hours
Plasma β-OHB
6 hours
Study Arms (2)
Ketone
EXPERIMENTALKetone monester (beta-hydroxybutyrate (β-OHB)
Placebo
PLACEBO COMPARATORNon-caloric placebo
Interventions
Ketone - beta-hydroxybutyrate (β-OHB)
Eligibility Criteria
You may qualify if:
- Diagnosed with type 2 diabetes by a physician, a current HbA1c of 6.5-8.5%, and receiving treatment with lifestyle advice or oral glucose-lowering medications.
- Non-smoking
- Blood pressure \<160/100 mm/Hg
You may not qualify if:
- Exogenous insulin or SGLT2 inhibitors for type 2 diabetes treatment.
- Following a low-carbohydrate ketogenic diet, periodic fasting diet, or consuming ketogenic supplements.
- Other diagnosed chronic metabolic, cardiovascular, respiratory, neurological, or gastrointestinal disease.
- Smoker
- Blood pressure \>160/100 mm/Hg
- Lactose intolerant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Exeterlead
- University of British Columbiacollaborator
Study Sites (1)
Sport & Health Sciences, University of Exeter
Exeter, Devon, EX1 2LU, United Kingdom
Related Publications (1)
Monteyne AJ, Falkenhain K, Whelehan G, Neudorf H, Abdelrahman DR, Murton AJ, Wall BT, Stephens FB, Little JP. A ketone monoester drink reduces postprandial blood glucose concentrations in adults with type 2 diabetes: a randomised controlled trial. Diabetologia. 2024 Jun;67(6):1107-1113. doi: 10.1007/s00125-024-06122-7. Epub 2024 Mar 14.
PMID: 38483543DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blind
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2022
First Posted
August 26, 2022
Study Start
May 3, 2022
Primary Completion
December 2, 2022
Study Completion
November 1, 2023
Last Updated
May 21, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share