Type 2 DiabetesNCT05263401
Keto Drinks as a Meal Primer in Patients With Type 2 Diabetes
A study testing 3-hydroxybutyrate in people with Type 2 Diabetes and Ketoses, Metabolic, run by University of Aarhus at 1 site in Denmark.
Trial summary
The main objective of this clinical trial is to study the effects of orally administered ketone drinks containing the ketone body, 3-hydroxybutyrate (3-OHB), just before a meal in patients with type 2 diabetes. Moreover the investigators will compare the effects of two different ketone drinks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Ketoses, Metabolic
- What is being tested?
- 3-hydroxybutyrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2022to 30 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes diagnosis, metformin treated or dietary treated
- HbA1C < 80 mmol/mol
- 25 < BMI < 35
- Written consent
Who cannot join
- Severe comorbidity
- Treatment with insulin, GLP-1 analogues, SGLT-2-inhibitors or sulfonylureas
- Specific diets, e.g. ketogenic diet
- PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical research laboratory, Department of endocrinology, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: 3-hydroxybutyrate as a Meal Primer in Patients With Type 2 Diabetes
The main objective of this clinical trial is to study the effects of orally administered ketone drinks containing the ketone body, 3-hydroxybutyrate (3-OHB), just before a meal in patients with type 2 diabetes. Moreover the investigators will compare the effects of two different ketone drinks.
The hypothesis is:
3-OHB as a pre-meal may:
- Lower postprandial blood glucose and lipids.
- Mediate release of intestinal hormones and affect gastric emptying.
- Affect appetite and other subjective measures related to food intake.
The effects of 3-OHB as a pre-meal will be investigated by blood samples, isotopic tracers examinations, paracetamol test, questionnaires and meal test.
- Conditions
- Type 2 Diabetes, Ketoses, Metabolic
- Being tested
- 3-hydroxybutyrate
- Medical subject headings
- Diabetes Mellitus, Type 2, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-hydroxybutyrateDietary supplement
Orally administered pre-meal drinks.
| Study group | Role | What they receive |
|---|---|---|
| Ketone salt | Experimental | Na-D/L-3-hydroxybutyrate dissolved in tap water. Receives: Dietary Supplement: 3-hydroxybutyrate |
| Ketone ester | Experimental | (R)-3-Hydroxybutyl (R)-3-hydroxybutyrate Receives: Dietary Supplement: 3-hydroxybutyrate |
| Placebo | Placebo comparator | Tap water Receives: Dietary Supplement: 3-hydroxybutyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial P-glucose
Incremental area under the curve (iAUC) for P-glucose.
Measured: 3 hours
Secondary outcomes (15)
Postprandial free fatty acids (FFA)
Blood samples
Measured: 3 hours
Differences in circulating concentrations of 3-hydroxybutyrate
Blood samples
Measured: 3,5 hours
Lipolysis rate
Measures of palmitate flux (palmitate tracer)
Measured: 3 hours
Glucose kinetics
Glucose tracer examinations
Measured: 3 hours
Gastric emptying
Paracetamol test
Measured: 3 hours
Differences in hunger/satiety
Questionnaire for quantifying hunger/satiety on a VAS scale from 1-10
Measured: 4 hours
Differences in actual hunger
Ad libitum meal test
Measured: 30 minutes
Differences in circulating concentrations of insulin
Blood samples
Measured: 3,5 hours
Differences in circulating concentrations of glucagon
Blood samples
Measured: 3,5 hours
Differences in circulating concentrations of c-peptide
Blood samples
Measured: 3,5 hours
Differences in circulating concentrations of Glucagon-like peptide-1 (GLP-1)
Blood samples
Measured: 3,5 hours
Differences in circulating concentrations of Gastric inhibitory polypeptide (GIP)
Blood samples
Measured: 3,5 hours
Differences in circulating concentrations of ghrelin
Blood samples
Measured: 3,5 hours
Differences in circulating concentrations of cholecystokinin
Blood samples
Measured: 3,5 hours
Differences in circulating concentrations of gastrin
Blood samples
Measured: 3,5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Jan 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Niels Møller, Professor, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263401
- Sponsor's protocol ID
- 1-10-72-282-20
- Status last verified
- Dec 2021
- First submitted
- 14 Dec 2021
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pedersen MGB, Ghias E, Bangshaab M, Loung TV, Bengtsen MB, Svart MV, Sondergaard E, Gormsen LC, Moller N, Johannsen M, Rittig N. Ketosis elevates plasma concentrations of D-beta-hydroxybutyryl-phenylalanine (BHB-Phe) in humans. Nutr Metab (Lond). 2026 Jul 15. doi: 10.1186/s12986-026-01172-7. Online ahead of print.
PubMed 42458538Bangshaab M, Bengtsen MB, Smedegaard S, Sondergaard E, Moller N, Svart MV, Rittig N. Ketone supplementation dose-dependently lowers postprandial blood glucose, lipid and ghrelin levels in individuals with type 2 diabetes: a randomised crossover study. Diabetologia. 2026 Mar;69(3):752-763. doi: 10.1007/s00125-025-06614-0. Epub 2025 Nov 28.
PubMed 41315088
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-hydroxybutyrate as a Meal Primer in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05263401
- Acronym / sponsor ID
- 1-10-72-282-20
- Conditions
- Type 2 Diabetes, Ketoses, Metabolic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 2 Mar 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.
The main objective of this clinical trial is to study the effects of orally administered ketone drinks containing the ketone body, 3-hydroxybutyrate (3-OHB), just before a meal in patients with type 2 diabetes. Moreover the investigators will compare the effects of two different ketone drinks.
The hypothesis is:
3-OHB as a pre-meal may:
- Lower postprandial blood glucose and lipids.
- Mediate release of intestinal hormones and affect gastric emptying.
- Affect appetite and other subjective measures related to food intake.
The effects of 3-OHB as a pre-meal will be investigated by blood samples, isotopic tracers examinations, paracetamol test, questionnaires and meal test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketone salt | Experimental | Dietary Supplement: 3-hydroxybutyrateNa-D/L-3-hydroxybutyrate dissolved in tap water. |
| Ketone ester | Experimental | Dietary Supplement: 3-hydroxybutyrate(R)-3-Hydroxybutyl (R)-3-hydroxybutyrate |
| Placebo | Placebo comparator | Dietary Supplement: 3-hydroxybutyrateTap water |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes diagnosis, metformin treated or dietary treated
- HbA1C < 80 mmol/mol
- 25 < BMI < 35
- Written consent
Key exclusion criteria (4 listed)
- Severe comorbidity
- Treatment with insulin, GLP-1 analogues, SGLT-2-inhibitors or sulfonylureas
- Specific diets, e.g. ketogenic diet
- PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other)
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 |
|---|---|---|
| 3-hydroxybutyrateOrally administered pre-meal drinks. | Dietary supplement | Ketone ester, Ketone salt, Placebo |
Primary outcome
Postprandial P-glucose
Time frame: 3 hours
Incremental area under the curve (iAUC) for P-glucose.
15 secondary outcomes
Postprandial free fatty acids (FFA)
Time frame: 3 hours
Differences in circulating concentrations of 3-hydroxybutyrate
Time frame: 3,5 hours
Lipolysis rate
Time frame: 3 hours
Glucose kinetics
Time frame: 3 hours
Gastric emptying
Time frame: 3 hours
Differences in hunger/satiety
Time frame: 4 hours
Differences in actual hunger
Time frame: 30 minutes
Differences in circulating concentrations of insulin
Time frame: 3,5 hours
Differences in circulating concentrations of glucagon
Time frame: 3,5 hours
Differences in circulating concentrations of c-peptide
Time frame: 3,5 hours
Differences in circulating concentrations of Glucagon-like peptide-1 (GLP-1)
Time frame: 3,5 hours
Differences in circulating concentrations of Gastric inhibitory polypeptide (GIP)
Time frame: 3,5 hours
Differences in circulating concentrations of ghrelin
Time frame: 3,5 hours
Differences in circulating concentrations of cholecystokinin
Time frame: 3,5 hours
Differences in circulating concentrations of gastrin
Time frame: 3,5 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 4 Apr 2023.
- Derived from this study: PubMed 42458538Pedersen MGB, Ghias E, Bangshaab M, Loung TV, Bengtsen MB, Svart MV, Sondergaard E, Gormsen LC, Moller N, Johannsen M, Rittig N. Ketosis elevates plasma concentrations of D-beta-hydroxybutyryl-phenylalanine (BHB-Phe) in humans. Nutr Metab (Lond). 2026 Jul 15. doi: 10.1186/s12986-026-01172-7. Online ahead of print.
- Derived from this study: PubMed 41315088Bangshaab M, Bengtsen MB, Smedegaard S, Sondergaard E, Moller N, Svart MV, Rittig N. Ketone supplementation dose-dependently lowers postprandial blood glucose, lipid and ghrelin levels in individuals with type 2 diabetes: a randomised crossover study. Diabetologia. 2026 Mar;69(3):752-763. doi: 10.1007/s00125-025-06614-0. Epub 2025 Nov 28.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Niels Møller, Professor study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-hydroxybutyrate in people with Type 2 Diabetes and Ketoses, Metabolic, run by University of Aarhus at 1 site in Denmark.
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 4 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 4 Apr 2023. 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 Denmark. 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?
Postprandial P-glucose (time frame: 3 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 NCT05263401, which also lists 2 linked publications.
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 4 Apr 2023.