Diazoxide for Non-Alcoholic Fatty Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to compare a one-week course of diazoxide (2 mg/kg per dose x 14 doses) and placebo in people with obesity and insulin resistance (IR) with metabolic dysfunction-associated steatotic liver disease (MASLD). The main question it aims to answer are how mitigation of compensatory hyperinsulinemia with diazoxide affects hepatic de novo lipogenesis, a major contributor to MASLD pathophysiology.
Participants will:
* Take 14 doses of placebo over 7 days, followed 4-12 weeks later by either 14 doses of diazoxide (at 2 mg per kg of body weight per dose \[mpk\]) or another 14 doses of placebo, over 7 days
* Take 18 doses of heavy (deuterated) water (50 mL each) over 7 days, twice
* Have blood drawn and saliva collected after an overnight fast on four mornings over the course of the study
* Undergo insulin suppression tests (IST) to assess the degree of insulin resistance at the end of each 1-week study period
* Consume their total calculated daily caloric needs as divided into three meals per day
Researchers will compare blood tests at the beginning and end of each 1-week study period in participants randomized (like the flip of a coin) to receive either placebo followed by diazoxide or placebo followed by placebo, to see how the drug treatment affects de novo lipogenesis, serum insulin, plasma glucose, and other serum lipid parameters (triglycerides, free fatty acids), among others.
Who Is on the Research Team?
Joshua R Cook, MD, PhD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 with obesity (BMI of 30-45 kg/m2) and prediabetes, who have a specific type of liver disease called MASLD. Participants should not be too insulin resistant (HOMA-IR score ≥ 2.73), and must have mild to moderate liver fat but no serious fibrosis.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive 14 doses of placebo over 7 days
Washout
A washout period of 4-12 weeks between treatment periods
Treatment Period 2
Participants receive either 14 doses of diazoxide or placebo over 7 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Diazoxide
Trial Overview
The study tests if diazoxide can lower the production of new fat in the liver compared to a placebo in people with fatty liver disease due to metabolic issues. It involves taking medication or placebo, drinking heavy water, blood draws, saliva collection, and undergoing insulin resistance tests over two one-week periods.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
During the first 1-week study period, participants will ingest a placebo solution at 14 doses over 7 days. During the second 1-week study period, 4-12 weeks later, participants will ingest diazoxide oral suspension at 2 mg per kg body weight per dose (14 doses over 7 days). Blinding will occur by completely covering single-dose oral syringes with labels. 80% of participants will be randomized to this arm.
During the first 1-week study period, participants will ingest a placebo solution at 14 doses over 7 days. During the second 1-week study period, 4-12 weeks later, participants will again ingest placebo solution (14 doses over 7 days). Blinding will occur by completely covering single-dose oral syringes with labels. 20% of participants will be randomized to this arm.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
University of California, Berkeley
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
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