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Glycemic Effect of Diazoxide in NAFLD

StatusCompleted
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results posted: Sep 30, 2026 Primary endpoints revised (4) · Enrollment target: 24 to 22 · Interventions: Deuterated water (2H2O/D2O) (Drug), Diazoxide oral suspension, 1 mg per kg per dose (Drug), Diazoxide oral suspension, 2 mg per kg per dose… to Deuterated water (2H2O/D2O) (Drug), Diazoxide oral suspension, 1 mg per kg per dose (Drug), Diazoxide oral suspension, 2 mg per kg per dose… · 3 more Show 6 more changesShow less
    • Primary endpoints revised (4)
    • Enrollment target: 24 to 22
    • Interventions: Deuterated water (2H2O/D2O) (Drug), Diazoxide oral suspension, 1 mg per kg per dose (Drug), Diazoxide oral suspension, 2 mg per kg per dose… to Deuterated water (2H2O/D2O) (Drug), Diazoxide oral suspension, 1 mg per kg per dose (Drug), Diazoxide oral suspension, 2 mg per kg per dose…
    • Eligibility criteria expanded, about 80 words
    • Secondary endpoints: 7 to 6
    • Study description revised
  2. Trial status: Active, Not Recruiting to Completed Study completion date changed from estimate of Dec 2025 to Sep 10, 2025v12 Show 1 more changeShow less
    • Study completion date changed from estimate of Dec 2025 to Sep 10, 2025
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 72 to confirmed 24 · Primary completion date changed from estimate of Aug 2025 to Sep 10, 2025 · Completion date: Oct 2025 to Dec 2025 · 1 morev11 Show 4 more changesShow less
    • Enrollment target: estimated 72 to confirmed 24
    • Primary completion date changed from estimate of Aug 2025 to Sep 10, 2025
    • Completion date: Oct 2025 to Dec 2025
    • Site details revised
  4. Enrollment target: 54 to 72 Eligibility criteria revisedv10 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Aug 2024 to Aug 2025 Completion date: Jan 2025 to Oct 2025 · Collaborators: 1 to 2v9 Show 2 more changesShow less
    • Completion date: Jan 2025 to Oct 2025
    • Collaborators: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

Show 7 earlier versionsHide 7 earlier versions
  1. Primary endpoints: 5 to 4 Eligibility criteria revised · Secondary endpoints: 6 to 7v8 Show 2 more changesShow less
    • Eligibility criteria revised
    • Secondary endpoints: 6 to 7

    See this version in full on ClinicalTrials.gov ↗

  2. Enrollment target: 24 to 54 Eligibility criteria shortened, about 10 wordsv7 Show 1 more changeShow less
    • Eligibility criteria shortened, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  3. Site contact updated Collaborators expanded, about 4 wordsv6 Show 1 more changeShow less
    • Collaborators expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  4. Interventions: Diazoxide oral suspension, 1 mg per kg per dose (Drug), Diazoxide oral suspension, 2 mg per kg per dose (Drug), FreeStyle Libre Pro… to Deuterated water (2H2O/D2O) (Drug), Diazoxide oral suspension, 1 mg per kg per dose (Drug), Diazoxide oral suspension, 2 mg per kg per dose… Secondary endpoints: 10 to 6 · Study description expanded, about 30 words · Eligibility criteria shortened, about 4 wordsv5 Show 3 more changesShow less
    • Secondary endpoints: 10 to 6
    • Study description expanded, about 30 words
    • Eligibility criteria shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  5. Start date changed from estimate of May 2023 to Aug 1, 2023 Eligibility criteria expanded, about 64 words · Study description expanded, about 10 wordsv4 Show 2 more changesShow less
    • Eligibility criteria expanded, about 64 words
    • Study description expanded, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  6. Re-verified, no change to tracked fieldsv3
  7. Start date: Mar 2023 to May 2023 Eligibility criteria shortened, about 102 words · Study description shortened, about 2 wordsv2 Show 2 more changesShow less
    • Eligibility criteria shortened, about 102 words
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05729282
Lead Sponsor Columbia University
Collaborators: University of California, Berkeley, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Hyperinsulinemia, Insulin Resistance, Non-Alcoholic Fatty Liver Disease, Prediabetic State
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov