Glycemic Effect of Diazoxide in NAFLD

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

August 1, 2023

Primary Completion Date

September 10, 2025

Study Completion Date

December 31, 2025

Conditions
HyperinsulinemiaInsulin ResistanceNon-Alcoholic Fatty Liver DiseasePrediabetic State
Interventions
DRUG

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).

DRUG

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).

DRUG

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).

DEVICE

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.

DRUG

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.

Trial Locations (1)

10032

Columbia University Irving Medical Center, New York

All Listed Sponsors
collaborator

University of California, Berkeley

OTHER

collaborator

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

NIH

lead

Columbia University

OTHER