Diazoxide Suppression Test P&F Study
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorColumbia University
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Diazoxide, 3 mg/kg per dose
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Columbia University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Pisa
Collaborator
Source ClinicalTrials.gov