Type 2 DiabetesNCT06324669
The Effect of a Ketone Drink on Blood Glucose Levels in People With Type 2 Diabetes
A study testing Ketone supplement in people with Type 2 Diabetes, run by University of Exeter at 1 site in United Kingdom.
Trial summary
Ketones are naturally produced by our body and can affect our blood sugar levels. Ketones could be important in the treatment of type 2 diabetes (T2D). The purpose of this research is to determine if a ketone drink can lower blood sugar in people with T2D following a meal. Read more about this study
- Who is it for?
- Ages 41 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Ketone supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Mar 2024to 26 Jan 2025
- 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 41 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 41-70 years old
- Body mass index 27-40 mg/m²
- Type 2 diagnosis for more than 1 year
- HbA1c >6%
Who cannot join
- Currently following ketogenic diet
- Use of insulin
- HbA1c >10%
- Recent weight loss (>5kg in 6 months)
- Recent eGFR <30mL/min
- Heart failure
Show all 11Show fewer
- Substance abuse
- Cancer
- Myocardial infarction within 6 months
- Pregnancy or consideration of
- Use of antipsychotic drugs
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
Official title: Investigating the Blood Glucose Lowering Effect of Exogenous Ketone Ingestion in People With Type 2 Diabetes
Ketones are naturally produced by our body and can affect our blood sugar levels. Ketones could be important in the treatment of type 2 diabetes (T2D). The purpose of this research is to determine if a ketone drink can lower blood sugar in people with T2D following a meal. This research will provide new knowledge about the regulation of blood sugar. This may also inform if ketone drinks could be used as a treatment for T2D.
- Conditions
- Type 2 Diabetes
- Being tested
- Ketone supplement, Placebo supplement
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone supplementDietary supplement
100 mL flavoured drink containing 0.3 g/kg ketone monoester ((R)-3-hydroxybutyl (R)-3-hydroxybutyrate; ΔG®, University of Oxford; https://www.deltagketones.com) consumed 30 min prior to a mixed meal tolerance test, on 2 occasions during test day
Placebo supplementDietary supplement
Placebo with stevia and bitter agent to flavour match, consumed 30 min prior to a mixed meal tolerance test, on 2 occasions during test day
| Study group | Role | What they receive |
|---|---|---|
| Ketone supplementation | Experimental | 100 mL flavoured drink containing 0.3 g/kg ketone monoester ((R)-3-hydroxybutyl (R)-3-hydroxybutyrate; ΔG®, University of Oxford; https://www.deltagketones.com) Receives: Dietary Supplement: Ketone supplement |
| Placebo | Placebo comparator | Placebo with stevia and bitter agent to flavour match Receives: Dietary Supplement: Placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of endogenous glucose production
Rate of endogenous glucose production over 4 hours in response to a meal measured by blood sample
Measured: 4 hours
Secondary outcomes (14)
Total rate of glucose appearance
Total rate of glucose appearance measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal
Measured: 4 and 8 hours
Exogenous glucose rate of appearance
Exogenous rate of glucose appearance measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal
Measured: 4 and 8 hours
Total rate of glucose disappearance
Total rate of glucose disappearance measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal
Measured: 4 and 8 hours
Rate of gluconeogenesis
Rate of gluconeogenesis measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal
Measured: 4 and 8 hours
Rate of glycogenolysis
Rate of glycogenolysis measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal
Measured: 4 and 8 hours
Beta-cell function
Beta-cell function using dynamic modelling of insulin/c-peptide secretion over 4 and 8 hours following a meal
Measured: 4 and 8 hours
Insulin concentration
Insulin concentration using ELISA assay over 4 and 8 hours following a meal
Measured: 4 and 8 hours
Glucagon concentration
Glucagon concentration using ELISA assay over 4 and 8 hours following a meal
Measured: 4 and 8 hours
GLP-1 concentration
GLP-1 using ELISA assay over 4 and 8 hours following a meal
Measured: 4 and 8 hours
GIP concentration
GIP concentration using ELISA assay over 4 and 8 hours following a meal
Measured: 4 and 8 hours
Glycerol concentration
Glycerol concentration using colorimetric assay over 4 and 8 hours following a meal
Measured: 4 and 8 hours
Free fatty acid concentration
Free fatty acids using colorimetric assay over 4 and 8 hours following a meal
Measured: 4 and 8 hours
Ketone concentration
Ketone concentration using colorimetric assay over 4 and 8 hours following a meal
Measured: 4 and 8 hours
Energy expenditure
Energy expenditure using indirect calorimetry over 4 and 8 hours following a meal
Measured: 4 and 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start16 Mar 2024
- Primary completion26 Jan 2025
- Study completion26 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Randomised cross over trial counterbalanced for trial order
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Francis B Stephens, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324669
- Sponsor's protocol ID
- 4765060
- Status last verified
- Apr 2025
- First submitted
- 12 Mar 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Blood Glucose Lowering Effect of Exogenous Ketone Ingestion in People With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06324669
- Acronym / sponsor ID
- 4765060
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- University of British Columbia, Medical Research Council
- Study start
- 16 Mar 2024 (actual)
- Primary completion
- 26 Jan 2025 (actual)
- Study completion
- 26 Jan 2025 (actual)
- First posted
- 22 Mar 2024 (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.
Ketones are naturally produced by our body and can affect our blood sugar levels. Ketones could be important in the treatment of type 2 diabetes (T2D). The purpose of this research is to determine if a ketone drink can lower blood sugar in people with T2D following a meal. This research will provide new knowledge about the regulation of blood sugar. This may also inform if ketone drinks could be used as a treatment for T2D.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised cross over trial counterbalanced for trial order
| Arm | Type | Receives |
|---|---|---|
| Ketone supplementation | Experimental | Dietary Supplement: Ketone supplement100 mL flavoured drink containing 0.3 g/kg ketone monoester ((R)-3-hydroxybutyl (R)-3-hydroxybutyrate; ΔG®, University of Oxford; https://www.deltagketones.com) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo supplementPlacebo with stevia and bitter agent to flavour match |
Who may qualify
- Ages
- 41 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 41-70 years old
- Body mass index 27-40 mg/m²
- Type 2 diagnosis for more than 1 year
- HbA1c >6%
Key exclusion criteria (11 listed)
- Currently following ketogenic diet
- Use of insulin
- HbA1c >10%
- Recent weight loss (>5kg in 6 months)
- Recent eGFR <30mL/min
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 supplement100 mL flavoured drink containing 0.3 g/kg ketone monoester ((R)-3-hydroxybutyl (R)-3-hydroxybutyrate; ΔG®, University of Oxford; https://www.deltagketones.com) consumed 30 min prior to a mixed meal tolerance test, on 2 occasions during test day | Dietary supplement | Ketone supplementation |
| Placebo supplementPlacebo with stevia and bitter agent to flavour match, consumed 30 min prior to a mixed meal tolerance test, on 2 occasions during test day | Dietary supplement | Placebo |
Primary outcome
Rate of endogenous glucose production
Time frame: 4 hours
Rate of endogenous glucose production over 4 hours in response to a meal measured by blood sample
14 secondary outcomes
Total rate of glucose appearance
Time frame: 4 and 8 hours
Exogenous glucose rate of appearance
Time frame: 4 and 8 hours
Total rate of glucose disappearance
Time frame: 4 and 8 hours
Rate of gluconeogenesis
Time frame: 4 and 8 hours
Rate of glycogenolysis
Time frame: 4 and 8 hours
Beta-cell function
Time frame: 4 and 8 hours
Insulin concentration
Time frame: 4 and 8 hours
Glucagon concentration
Time frame: 4 and 8 hours
GLP-1 concentration
Time frame: 4 and 8 hours
GIP concentration
Time frame: 4 and 8 hours
Glycerol concentration
Time frame: 4 and 8 hours
Free fatty acid concentration
Time frame: 4 and 8 hours
Ketone concentration
Time frame: 4 and 8 hours
Energy expenditure
Time frame: 4 and 8 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 18 Apr 2025.
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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.
Francis B Stephens, PhD principal investigator
University of Exeter
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 supplement in people with Type 2 Diabetes, 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 4 inclusion and 11 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 18 Apr 2025. 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?
Rate of endogenous glucose production (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2025.