Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1

PHASE1CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

January 7, 2019

Primary Completion Date

August 30, 2024

Study Completion Date

December 30, 2024

Conditions
Heart FailureType 2 Diabetes Mellitus
Interventions
DRUG

Beta-hydroxy-butyrate

"Following completion of the baseline MRI and blood samples, subjects will be divided into three groups (26 subjects per group). Each group will receive a 6-hour (3-hour in group III) prime-continuous infusion of racemic B-OH-B (100 mg/mL solution; pH adjusted to 7.4) to increase the plasma B-OH-B concentration by 0.5, 2.0, and 5.0 mmol/L.~GROUP I: Prime = 0.4 mg/kg.min for 20 minutes and constant rate = 0.2 mg/kg.min until study end GROUP II: Prime = 1.5 mg/kg.min for 20 minutes and constant rate = 0.75 mg/kg.min until study end GROUP III: Prime = 4.0 mg/kg.min for 20 minutes and constant rate = 2.0 mg/kg.min until study end"

Trial Locations (2)

78207

Texas Diabetes Institute - University Health System, San Antonio

78229

University of Texas Health Science Center San Antonio, San Antonio

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

The University of Texas Health Science Center at San Antonio

OTHER

NCT03560323 - Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1 | Biotech Hunter | Biotech Hunter