Diabetes MellitusKES2NCT05518448
The Effect of a Ketone Drink on Liver Glucose Production in People With Type 2 Diabetes
A study testing Ketone - beta-hydroxybutyrate (β-OHB) in people with Diabetes Mellitus and Ketosis, run by University of Exeter at 1 site in United Kingdom.
Trial summary
What is the effect of a ketone drink on liver glucose production, and postprandial glycemia, in people with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Diabetes Mellitus, Ketosis
- What is being tested?
- Ketone - beta-hydroxybutyrate (β-OHB)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 May 2022to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sport & Health Sciences, University of Exeter
Exeter, Devon, EX1 2LU
About this study
What is the effect of a ketone drink on liver glucose production, and postprandial glycemia, in people with type 2 diabetes.
Read the detailed description
Background: Ketones are molecules that are naturally produced by our body during fasting or diets low in carbohydrates. Ketones can affect how our liver produces and maintains our body's blood sugar levels, which could be important in the management of type 2 diabetes (T2D), where high blood sugar levels are partly because of excess sugar production by the liver.
Objectives: To determine if, and how, a ketone drink can lower blood glucose in people with T2D following a meal.
Methods: Twelve people with T2D will visit our laboratory in the morning on two occasions and ingest a drink containing ketones or placebo on each visit in a random order before ingesting a milkshake style drink containing sugar. Blood samples will then be taken at regular intervals over 4 hours to determine if the ketone drink has lowered blood sugar levels in response to the meal, and if this was due to reduced sugar production by the liver.
Value: This research will provide new knowledge about the regulation of liver blood sugar production in response to ketone ingestion. This may also inform future clinical trials to establish if ketone drinks could be used as a treatment for T2D.
- Conditions
- Diabetes Mellitus, Ketosis
- Being tested
- Ketone - beta-hydroxybutyrate (β-OHB)
- Keywords
- Diabetes, Exogenous ketones, Postprandial glycemia, Endogenous glucose production
- Medical subject headings
- Diabetes Mellitus, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone - beta-hydroxybutyrate (β-OHB)Dietary supplement
Ketone - beta-hydroxybutyrate (β-OHB)
| Study group | Role | What they receive |
|---|---|---|
| Ketone | Experimental | Ketone monester (beta-hydroxybutyrate (β-OHB) Receives: Dietary Supplement: Ketone - beta-hydroxybutyrate (β-OHB) |
| Placebo | Placebo comparator | Non-caloric placebo Receives: Dietary Supplement: Ketone - beta-hydroxybutyrate (β-OHB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EGP
Endogenous glucose production
Measured: 6 hours
Secondary outcomes (3)
Postprandial glycemia
Postprandial glucose concentrations
Measured: 4 hours
Insulin
Serum insulin concentration
Measured: 6 hours
Plasma β-OHB
Plasma β-OHB concentrations
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start3 May 2022
- Primary completion2 Dec 2022
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Ketone vs placebo crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518448
- Sponsor's protocol ID
- 22-02-02-B-01
- Acronym
- KES2
- Status last verified
- May 2024
- First submitted
- 24 Aug 2022
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38483543
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Ketone Drink on Liver Glucose Production in People With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05518448
- Acronym / sponsor ID
- KES2 / 22-02-02-B-01
- Conditions
- Diabetes Mellitus, Ketosis
- Keywords
- Diabetes, Exogenous ketones, Postprandial glycemia, Endogenous glucose production
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- 3 May 2022 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
What is the effect of a ketone drink on liver glucose production, and postprandial glycemia, in people with type 2 diabetes.
Detailed description
Background: Ketones are molecules that are naturally produced by our body during fasting or diets low in carbohydrates. Ketones can affect how our liver produces and maintains our body's blood sugar levels, which could be important in the management of type 2 diabetes (T2D), where high blood sugar levels are partly because of excess sugar production by the liver.
Objectives: To determine if, and how, a ketone drink can lower blood glucose in people with T2D following a meal.
Methods: Twelve people with T2D will visit our laboratory in the morning on two occasions and ingest a drink containing ketones or placebo on each visit in a random order before ingesting a milkshake style drink containing sugar. Blood samples will then be taken at regular intervals over 4 hours to determine if the ketone drink has lowered blood sugar levels in response to the meal, and if this was due to reduced sugar production by the liver.
Value: This research will provide new knowledge about the regulation of liver blood sugar production in response to ketone ingestion. This may also inform future clinical trials to establish if ketone drinks could be used as a treatment for T2D.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Ketone vs placebo crossover
| Arm | Type | Receives |
|---|---|---|
| Ketone | Experimental | Dietary Supplement: Ketone - beta-hydroxybutyrate (β-OHB)Ketone monester (beta-hydroxybutyrate (β-OHB) |
| Placebo | Placebo comparator | Dietary Supplement: Ketone - beta-hydroxybutyrate (β-OHB)Non-caloric placebo |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketone - beta-hydroxybutyrate (β-OHB)Ketone - beta-hydroxybutyrate (β-OHB) | Dietary supplement | Ketone, Placebo |
Primary outcome
EGP
Time frame: 6 hours
Endogenous glucose production
3 secondary outcomes
Postprandial glycemia
Time frame: 4 hours
Insulin
Time frame: 6 hours
Plasma β-OHB
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Derived from this study: PubMed 38483543Monteyne 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone - beta-hydroxybutyrate (β-OHB) in people with Diabetes Mellitus and Ketosis, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EGP (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05518448, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.