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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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~up to study day 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to study day 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fasting plasma glucose (absolute values)
Fasting plasma glucose (relative/change)
Fasting plasma/serum insulin (absolute values)
+1 more
Secondary outcome measures
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 more
Other outcome measures
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 more

Trial 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
1,433 Previous Clinical Trials
2,447,205 Total Patients Enrolled
9 Trials studying Non-alcoholic Fatty Liver Disease
247 Patients Enrolled for Non-alcoholic Fatty Liver Disease
University of California, BerkeleyOTHER
181 Previous Clinical Trials
721,102 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
32 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Joshua R Cook, MD, PhDPrincipal InvestigatorColumbia University
5 Previous Clinical Trials
131 Total Patients Enrolled
4 Trials studying Non-alcoholic Fatty Liver Disease
113 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Diazoxide (Potassium Channel Activator) Clinical Trial Eligibility Overview. Trial Name: NCT05729282 — Phase 1
Non-alcoholic Fatty Liver Disease Research Study Groups: Placebo, Diazoxide oral suspension, 1 mg per kg per dose, Diazoxide oral suspension, 2 mg per kg per dose
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Diazoxide Highlights & Side Effects. Trial Name: NCT05729282 — Phase 1
Diazoxide (Potassium Channel Activator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05729282 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial accepting elderly volunteers?

"The minimal and maximal age requirements for potential participants of this trial are 18 years old and 65 respectively."

Answered by AI

Has the FDA officially sanctioned Diazoxide oral suspension, 1 mg per kg per dose?

"The safety of Diazoxide oral suspension, 1 mg per kg per dose received a rating of one due to the Phase 1 trial status. This implies that its efficacy and safety are backed by limited clinical evidence."

Answered by AI

Are there any vacancies available for this clinical trial at present?

"Affirmative. According to the information published on clinicaltrials.gov, this research is currently recruiting participants. The study began its recruitment process on March 1st 2023 and was most recently updatedFebruary 6th of that same year. A total of 24 patients need to be recruited from one medical facility for this trial."

Answered by AI

What is the enrollment cap of participants for this research project?

"Yes, the information on clinicaltrials.gov is clear that this medical trial is currently in recruitment mode. It was initially posted on March 1st 2023 and has been updated as recently as February 6th of the same year. The study requires 24 participants from one single site to be enrolled."

Answered by AI

What are the anticipated outcomes of this research project?

"This clinical trial, lasting up to 15 study days, will assess the efficacy of diazoxide by measuring participants' fasting plasma glucose level. Secondary objectives include assessing changes in serum triglycerides and free fatty acids levels between 1 MPK and 2 MPK dosages versus placebo."

Answered by AI

Is it feasible for me to sign up for this investigation?

"This medical research is seeking 24 patients aged 18-65, with insulin resistance and metabolic associated fatty liver disease. Additionally, they must be able to understand either English or Spanish; possess a body mass index of 27-35 kg/m2; have pre-randomization screening labs drawn within two weeks of giving informed consent; and display prediabetes HbA1c levels between 5.7%-6.4%, fasting plasma glucose between 100-125 mg/dL after an 8 hour fast, and fasting hyperinsulinemia (fasting insulin level ≥ 15 µIU/mL). The patient also needs to sign the written"

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Columbia University Irving Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Glycemic Effect of Diazoxide in NAFLD
Joshua Cook 2023. "Glycemic Effect of Diazoxide in NAFLD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05729282.
All > Nafld > Pre Diabetes
~13 spots leftby Aug 2024
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