Diazoxide Suppression Test P&F Study

ConditionsInsulin Resistance Hyperinsulinemia Obesity

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Diazoxide, 3 mg/kg per dose
Drug
Insulin anti-secretagogue taken for 8 doses over 4 days

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: DiazoxideExperimental treatment 1 intervention

Trial outcomes