Diazoxide for Non-Alcoholic Fatty Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assess how diazoxide affects individuals with non-alcoholic fatty liver disease who also face obesity and insulin resistance (when the body doesn’t respond well to insulin). It will compare diazoxide to a placebo by examining changes in liver fat production and insulin levels. Participants will initially receive placebo doses, followed by either more placebo or diazoxide. The trial seeks individuals who have been managing fatty liver disease and insulin resistance. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, certain medications used for specific conditions are not allowed within 90 days prior to screening, such as antidiabetic medications (except metformin), fibrates, and some psychiatric drugs. It's best to discuss your current medications with the trial team to see if they are permitted.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that diazoxide may help with liver problems. In earlier studies, diazoxide reduced signs of liver damage, suggesting it might protect the liver. It also lowers insulin release, which benefits people with insulin resistance.
Regarding safety, diazoxide is usually well-tolerated. However, this study is in the early stages and mainly focuses on the treatment's safety for humans. While initial studies suggest it is safe, more research is needed to confirm this. Always consult a healthcare provider before joining a trial.12345Why do researchers think this study treatment might be promising?
Most treatments for non-alcoholic fatty liver disease (NAFLD) focus on lifestyle changes like diet and exercise, or medications that manage symptoms such as insulin resistance or high cholesterol. But diazoxide works differently by targeting the metabolic processes that contribute to the disease. Researchers are excited about diazoxide because it opens up the possibility of directly influencing liver fat accumulation through its unique mechanism of action, potentially leading to more effective management of NAFLD.
What evidence suggests that diazoxide might be an effective treatment for MASLD?
Research has shown that diazoxide may help treat non-alcoholic fatty liver disease (NAFLD). In this trial, participants will be randomized into different arms to assess its effectiveness. Studies have found that diazoxide can reduce signs of liver damage and protect the liver. It lowers insulin levels, which helps control the buildup of new fat in the liver—a major issue in this condition. Earlier research discovered that diazoxide reduced belly fat and fatty liver in pre-diabetic rats. These findings suggest that diazoxide could be a promising treatment for liver issues in people with obesity and insulin resistance.13467
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
Citations
NCT05729282 | 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 ...
Diazoxide for Non-alcoholic Fatty Liver Disease
Studies have shown that diazoxide can lower signs of liver injury, potentially protecting the liver. Additionally, diazoxide reduces insulin release, which ...
Diazoxide for Non-Alcoholic Fatty Liver Disease
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 ...
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 ...
5.
researchgate.net
researchgate.net/publication/5660595_Diazoxide_prevents_abdominal_adiposity_and_fatty_liver_in_obese_OLETF_rats_at_prediabetic_stageDiazoxide prevents abdominal adiposity and fatty liver in ...
Occurrences of abdominal adiposity and fatty liver were markedly reduced by diazoxide treatment. Diazoxide significantly lowered ...
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 ...
Comparative efficacy of multiple drugs for non-alcoholic fatty ...
Overall, GLP-1RA is effective in weight management, reducing liver enzymes and hepatic fat content, improving insulin resistance, and slowing ...
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