Your session is about to expire
← Back to Search
Potassium Channel Activator
Diazoxide for Non-alcoholic Fatty Liver Disease
Phase 1
Recruiting
Led By Joshua R Cook, MD, PhD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to study day 15
Summary
This trial will compare 2 doses of diazoxide to placebo to see how they affect glucose and fat metabolism in people with IR-NAFLD. Participants will take 27 doses, have fasting blood tests and wear a glucose monitor for 14 days.
Who is the study for?
Adults aged 18-70 with overweight/obesity and insulin resistance, at high risk for or diagnosed with NAFLD. Must have prediabetes indicators like fasting plasma glucose of 100-125 mg/dL or HbA1c of 5.7-6.4%. Excludes those with diabetes, abnormal heart rates, recent significant weight loss, certain medical conditions including active COVID-19 within screening period, psychiatric diseases decompensated within a year, known allergies to trial drugs, and women not using effective contraception.
What is being tested?
The trial tests diazoxide's effect on glucose and lipid metabolism in people with insulin resistance and NAFLD over two weeks. Participants will take diazoxide (1 or 2 mg per kg) or placebo daily while monitoring blood sugar continuously and having regular blood draws to measure the impact on plasma glucose and serum lipids.
What are the potential side effects?
Potential side effects include low blood sugar levels due to its action as an insulin inhibitor which might cause dizziness or fainting; fluid retention leading to swelling in legs; increased uric acid levels possibly resulting in gout; fatigue; headache; nausea; heart-related issues such as palpitations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to study day 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to study day 15
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fasting plasma glucose (absolute values)
Fasting plasma glucose (relative/change)
Fasting plasma/serum insulin (absolute values)
+1 moreSecondary study objectives
Continuous glucose monitoring (CGM) profile
Fasting serum or plasma free fatty acids (FFA) (absolute values)
Fasting serum or plasma free fatty acids (FFA) (relative/change)
+4 moreOther study objectives
Deuterium tracer enrichment in body water (measured in blood)
Deuterium tracer enrichment in body water (measured in saliva)
Hepatic de novo lipogenesis (absolute values)
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Diazoxide oral suspension, 2 mg per kg per doseExperimental Treatment3 Interventions
Participants will ingest diazoxide oral suspension at 2 mg per kg body weight per dose (27 doses over 14 days). Blinding will occur by completely covering single-dose oral syringes with labels.
Group II: Diazoxide oral suspension, 1 mg per kg per doseExperimental Treatment3 Interventions
Participants will ingest diazoxide oral suspension at 1 mg per kg body weight per dose (27 doses over 14 days). Blinding will occur by completely covering single-dose oral syringes with labels.
Group III: PlaceboPlacebo Group3 Interventions
Participants will ingest a placebo solution (27 doses over 14 days) formulated to approximate the taste of diazoxide oral suspension. Blinding will occur by completely covering single-dose oral syringes with labels.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FreeStyle Libre Pro
2023
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,663,136 Total Patients Enrolled
11 Trials studying Non-alcoholic Fatty Liver Disease
278 Patients Enrolled for Non-alcoholic Fatty Liver Disease
University of California, BerkeleyOTHER
186 Previous Clinical Trials
640,694 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
68 Patients Enrolled for Non-alcoholic Fatty Liver Disease
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,350 Total Patients Enrolled
56 Trials studying Non-alcoholic Fatty Liver Disease
10,118 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can provide informed consent in English or Spanish.Your insulin levels are too high when you haven't eaten for a while.I am between 18 and 65 years old and use effective birth control.Your HbA1c level is between 5.7% and 6.4%, which means you have prediabetes.I have signs of insulin resistance, such as prediabetes or high fasting insulin.I am between 18 and 70 years old and use effective birth control.I understand English or Spanish.I have been diagnosed with or am at high risk for fatty liver disease.I have given my written consent in English or Spanish for all study procedures.I have been diagnosed with non-alcoholic fatty liver disease by a specialist.You have given written permission (in English or Spanish) to participate in the study and for the study team to perform any necessary tests or procedures.Your blood sugar levels are between 100-125 mg/dL after fasting for at least 8 hours.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Diazoxide oral suspension, 1 mg per kg per dose
- Group 3: Diazoxide oral suspension, 2 mg per kg per dose
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Learn More About These Treatments
Share this study with friends
Copy Link
Messenger