Diazoxide Suppression Test P&F Study (NCT06606327) | Clinical Trial Compass
TerminatedPhase 1
Diazoxide Suppression Test P&F Study
Stopped: Reprioritization of research efforts
United States1 participantsStarted 2024-10-23
Plain-language summary
The goal of this study is to learn about how the hormone insulin controls blood sugar. The main question it aims to answer is about how much insulin the body actually needs to maintain a normal blood sugar level. People with obesity and high insulin levels will receive eight doses of diazoxide, a drug that suppresses the pancreas's production of insulin, and will have their fasting blood sugar and insulin levels checked daily while taking the drug.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women, aged 18-65 years
* Body mass index of 30-45 kg/m2
* Able to understand written and spoken English and/or Spanish
* Fasting hyperinsulinemia (fasting serum insulin ≥ 13 μU/mL)
* Completion of the graded insulin suppression test (GIST) protocol (Group H)
* Written informed consent (in English or Spanish) and any locally required authorization (e.g., Health Insurance Portability and Accountability Act) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations.
Exclusion Criteria:
* Unable to provide informed consent in English or Spanish
* Documented weight loss of ≥ 5% of baseline within the previous 3 months
* Abnormal blood pressure (including on treatment, if prescribed): Systolic blood pressure \< 90 mm Hg or \> 160 mm Hg, and/or Diastolic blood pressure \< 60 mm Hg or \> 100 mm Hg
* Abnormal resting heart rate: \< 60 or ≥ 110 bpm
* Sinus brady- or tachycardia that has been worked up and considered benign by the recruit's personal physician may be permitted at the PI's discretion
* Abnormal screening electrocardiogram on GIST screening (or if on file, performed within previous 90 d):
* Non-sinus rhythm
* Heart conduction blocks
* Previously unknown ischaemic changes that persist on repeat EKG:
* ST elevations
* T-wave inversions in a vascular distribution
* Laboratory evidence of dysglycemia on GIST screening:
* Hemoglobin A1c ≥ 5.7%, and/or
* Fasting plasma gluc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fasting plasma glucose
Timeframe: Baseline and after 4 days of diazoxide treatment
2
Fasting serum insulin
Timeframe: Baseline and after 4 days of diazoxide treatment