24
Participants
Start Date
August 1, 2023
Primary Completion Date
September 10, 2025
Study Completion Date
December 31, 2025
Diazoxide oral suspension, 1 mg per kg per dose
Diazoxide oral suspension provided in label-obscured single-use oral syringes at 1 mg per kg per dose (total of 27 doses over 14 days).
Diazoxide oral suspension, 2 mg per kg per dose
Diazoxide oral suspension provided in label-obscured single-use oral syringes at 2 mg per kg per dose (total of 27 doses over 14 days).
Placebo
Flavor-approximate placebo consisting of peppermint extract in diet tonic water, thickened with xanthan gum, provided in label-obscured single-use oral syringes at 2 mg per kg per dose (total of 27 doses over 14 days).
FreeStyle Libre Pro
All participants will wear a FreeStyle Libre Pro continuous glucose monitor (CGM) to track glycemic trends in response to study treatments. Investigators and participants will be blinded to CGM readings until after each participant has completed the trial.
Deuterated water (2H2O/D2O)
All participants will consume 32 aliquots of deuterated water (2H2O/D2O) 50 mL over 14 days to assess hepatic de novo lipogenesis. Tracer enrichment will be determined in blood and saliva.
Columbia University Irving Medical Center, New York
University of California, Berkeley
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Columbia University
OTHER