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NCT05729282 · ClinicalTrials.gov registry record · Phase 1
Glycemic Effect of Diazoxide in NAFLD
A Phase 1 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT05729282 is a Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 24 participants.
The verdict
NCT05729282, a Phase 1 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study 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 overweight/obesity and insulin resistance (IR) with, or at high risk for, non-alcoholic fatty liver disease (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 and 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 * Take 32 doses of heavy (deuterated) water (50 mL each) over 14 days * Have blood drawn and saliva collected after an overnight fast on four 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). They will also consume heavy (deuterated) water to assess de novo lipogenesis (building of new fatty acids by the liver).
Interventions
- DRUG Placebo
- DEVICE FreeStyle Libre Pro
- DRUG Diazoxide oral suspension, 1 mg per kg per dose
- DRUG Diazoxide oral suspension, 2 mg per kg per dose
- DRUG Deuterated water (2H2O/D2O)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-08-01 |
| Est. Completion | 2025-09-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05729282
The ClinicalTrials.gov registry entry for NCT05729282 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT05729282 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05729282 about?
NCT05729282 is a clinical study titled "Glycemic Effect of Diazoxide in NAFLD". The goal of this clinical trial is to compare a two-week course of diazoxide (at two different doses) and placebo in people with overweight/obesity and insulin resistance (IR) with, or at high risk for, non-alcoholic fatty liver disease (NAFLD). The main questions it aims to answer are how mitigatio...
What is the current status of trial NCT05729282?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-08-01. Estimated completion is 2025-09-10.
What interventions are being tested in trial NCT05729282?
The interventions under investigation include: Placebo (DRUG), FreeStyle Libre Pro (DEVICE), Diazoxide oral suspension, 1 mg per kg per dose (DRUG), Diazoxide oral suspension, 2 mg per kg per dose (DRUG), Deuterated water (2H2O/D2O) (DRUG).
Who is sponsoring clinical trial NCT05729282?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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