RecruitingNot Applicable

Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function

United States30 participantsStarted 2023-06-06

Plain-language summary

This study is being done to evaluate how a ketone ester (KE) supplement affects heart function and health in people with diabetes compared to a placebo supplement (made with standard food ingredients that do not contain ketone esters).

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 18 years old and ≤ 80 years old
. Type II Diabetes Mellitus
. Stable medical therapy for at least 1 months as determined by the treating physician (no plan to change between the two testing sessions)
. Dose of oral diuretics changes allowed, but must be stable for 1 week prior to randomization
. Body Mass Index (BMI) ≥ 25
. Ability to participate in exercise treadmill testing (only if CPET is performed)
. Ability to sign written consent

Exclusion criteria

. Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the trial
. Known allergy or sensitivity to Gadolinium based contrast agents
. Implanted pacemaker, cardioverter defibrillator, cardiac resynchronization therapy, left ventricular assist device
. Other metallic implants/aneurysm clips that are contraindicated in MRI

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Cardiac MRI measures of cardiac function

Timeframe: Baseline, 2 weeks

Trial details

NCT IDNCT06078683

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-31

Contact for this trial

Debbie Scandling, BS

614-688-5623 debbie.scandling@osumc.edu

View on ClinicalTrials.gov More Type 2 Diabetes trials