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Ketone drink may boost heart health in diabetes patients

NCT ID NCT06078683

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a ketone ester supplement can improve heart function and exercise ability in people with type 2 diabetes. About 30 adults will take either the supplement or a placebo and undergo heart scans and fitness tests. The goal is to see if this simple drink can ease the burden on the heart.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years old and ≤ 80 years old 2. Type II Diabetes Mellitus 3. Stable medical therapy for at least 1 months as determined by the treating physician (no plan to change between the two testing sessions) 4. Dose of oral diuretics changes allowed, but must be stable for 1 week prior to randomization 5. Body Mass Index (BMI) ≥ 25 6. Ability to participate in exercise treadmill testing (only if CPET is performed) 7. Ability to sign written consent Exclusion Criteria: 1. Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the trial 2. Known allergy or sensitivity to Gadolinium based contrast agents 3. Implanted pacemaker, cardioverter defibrillator, cardiac resynchronization therapy, left ventricular assist device 4. Other metallic implants/aneurysm clips that are contraindicated in MRI 5. Claustrophobia 6. History of severe kidney disease with eGFR\<30 ml/kg/1.73m2 7. Type I diabetes 8. History of diabetic ketoacidosis 9. Prior diagnosis of oxygen dependent pulmonary disease 10. Body Mass Index (BMI) \< 25 11. Major surgery (major according to the investigator's assessment) performed within 90 days prior to screening, or major scheduled elective surgery (e.g. hip replacement) within 90 days after screening 12. Acute or chronic liver disease, defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening 13. Gastrointestinal surgery or gastrointestinal disorder that might interfere with supplement consumption. Prior bariatric surgery allowed if weight-stable for past 3 months. 14. Any documented active or suspected malignancy or history of malignancy within 2 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix, or low-risk prostate cancer (subjects with pre-treatment prostate-specific antigen levels of \<10 ng/mL, and biopsy Gleason scores of ≤6 and clinical stage T1c or T2a) 15. Presence of any disease other than diabetes that results in a life expectancy of \<1 year (in the opinion of the investigator) 16. Current enrolment in another investigational device or drug study or completion within \<30 days of a trial of another investigational device or drug study. 17. Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, will make the subject unlikely to fulfil the trial requirements or complete the trial 18. Any other clinical condition that might jeopardize subject safety during participation in this trial or prevent the subject from adhering to the trial Protocol. 19. Unable or unwilling to follow guidelines of assigned supplement group. 20. Allergy to test article ingredients, or lactose intolerance 21. The subject cannot currently be on a low-carb diet plan. 30-day washout would be required. 22. Refusal to consent

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Ross Heart Hospital

    RECRUITING

    Columbus, Ohio, 43210, United States

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