Overview

Glycemic Effect of Diazoxide in NAFLD

Status:
Recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to compare a two-week course of diazoxide (at two different doses) and placebo in people with insulin resistance-associated non-alcoholic fatty liver disease (IR-NAFLD). The main questions it aims to answer are how mitigation of compensatory hyperinsulinemia with diazoxide affects parameters of glucose and lipid metabolism (how people with IR-NAFLD respond to lowering high insulin levels so that the investigators can see what happens to how the liver handles fat and sugar). Participants will: - Take 27 doses of diazoxide (at 1 mg per kg of body weight per dose [mpk] or 2 mpk) or of placebo, over 14 days - Have blood drawn after an overnight fast on six mornings over the two-week study period - Consume their total calculated daily caloric needs as divided into three meals per day - Wear a continuous glucose monitor for the two-week study period Researchers will compare fasting blood tests at intervals during the study period in participants randomized (like the flip of a coin) to diazoxide 1 mpk, diazoxide 2 mpk, or placebo, to see how the drug treatment affects plasma glucose, serum insulin, and serum lipid parameters (triglycerides, free fatty acids, and apolipoprotein B).
Phase:
Phase 1
Details
Lead Sponsor:
Columbia University
Treatments:
Diazoxide