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Recruiting NCT06078683

Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function

Trial Parameters

Condition Type 2 Diabetes
Sponsor Ohio State University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2023-06-06
Completion 2027-08-31
Interventions
Ketone Ester AcutePlacebo Acute

Brief 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).

Eligibility Criteria

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

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