Effects of Acute and Chronic Ketone Ester Consumption on Exercise Tolerance and Cardiac Function in Subjects With Diabetes
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Ohio
The Ross Heart Hospital
RECRUITING
Columbus
Contact Information
Primary
Debbie Scandling, BS
debbie.scandling@osumc.edu
614-688-5623
Backup
Christopher Crabtree, MS
crabtree.223@osu.edu
Time Frame
Start Date: 2023-06-06
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 30
Treatments
Experimental: Keto Ester Acute
This arm will provide a Ketone Ester supplement + a meal for consumption.
Placebo_comparator: Placebo Acute
This arm will provide a Placebo beverage + a meal for consumption.
Related Therapeutic Areas
Sponsors
Leads: Ohio State University