[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ketones-metabolism\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ketones-metabolism":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100522135","effects-of-ketone-ester-consumption-on-exercise-tolerance-and-cardiac-function-100522135",false,"NCT06078683","Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function","Effects of Acute and Chronic Ketone Ester Consumption on Exercise Tolerance and Cardiac Function in Subjects With Diabetes","Inclusion Criteria:\n\n1. Age ≥ 18 years old and ≤ 80 years old\n2. Type II Diabetes Mellitus\n3. Stable medical therapy for at least 1 months as determined by the treating physician (no plan to change between the two testing sessions)\n4. Dose of oral diuretics changes allowed, but must be stable for 1 week prior to randomization\n5. Body Mass Index (BMI) ≥ 25\n6. Ability to participate in exercise treadmill testing (only if CPET is performed)\n7. Ability to sign written consent\n\nExclusion Criteria:\n\n1. Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the trial\n2. Known allergy or sensitivity to Gadolinium based contrast agents\n3. Implanted pacemaker, cardioverter defibrillator, cardiac resynchronization therapy, left ventricular assist device\n4. Other metallic implants\u002Faneurysm clips that are contraindicated in MRI\n5. Claustrophobia\n6. History of severe kidney disease with eGFR\\\u003C30 ml\u002Fkg\u002F1.73m2\n7. Type I diabetes\n8. History of diabetic ketoacidosis\n9. Prior diagnosis of oxygen dependent pulmonary disease\n10. Body Mass Index (BMI) \\\u003C 25\n11. 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\n12. 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\n13. Gastrointestinal surgery or gastrointestinal disorder that might interfere with supplement consumption. Prior bariatric surgery allowed if weight-stable for past 3 months.\n14. 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 \\\u003C10 ng\u002FmL, and biopsy Gleason scores of ≤6 and clinical stage T1c or T2a)\n15. Presence of any disease other than diabetes that results in a life expectancy of \\\u003C1 year (in the opinion of the investigator)\n16. Current enrolment in another investigational device or drug study or completion within \\\u003C30 days of a trial of another investigational device or drug study.\n17. 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\n18. Any other clinical condition that might jeopardize subject safety during participation in this trial or prevent the subject from adhering to the trial Protocol.\n19. Unable or unwilling to follow guidelines of assigned supplement group.\n20. Allergy to test article ingredients, or lactose intolerance\n21. The subject cannot currently be on a low-carb diet plan. 30-day washout would be required.\n22. Refusal to consent","ALL","18 Years","80 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","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).",[27,28,29],"Type 2 Diabetes","Ketone Body Metabolism","Ketones, Metabolism","RECRUITING","2026-03-30",{"date":33,"type":34},"2026-04-03","ACTUAL",{"date":36,"type":34},"2023-06-06",{"date":38,"type":21},"2027-08-31",{"name":40,"class":41},"Ohio State University","OTHER"]