RecruitingPhase 1NCT06606327

Diazoxide Suppression Test P&F Study

Human Models of Primary Hyperinsulinemia: Diazoxide Suppression Test (DzST) Pilot & Feasibility Study


Sponsor

Columbia University

Enrollment

10 participants

Start Date

Oct 23, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a medication called diazoxide in people who have insulin resistance — a condition where the body produces too much insulin but it doesn't work properly, often linked to obesity. The goal is to see if the drug can suppress excess insulin, which may help with blood sugar control and weight management. **You may be eligible if...** - You are between 18 and 65 years old - You have a BMI between 30 and 45 (classified as obese) - You have elevated fasting insulin levels (fasting serum insulin ≥ 13 μU/mL) - You have completed a prior insulin sensitivity test (GIST protocol, Group H) - You can read and speak English or Spanish - You can give written informed consent **You may NOT be eligible if...** - You have lost 5% or more of your body weight in the past 3 months - You have uncontrolled high blood pressure (systolic above a set threshold) - You cannot give informed consent in English or Spanish Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDiazoxide, 3 mg/kg per dose

Insulin anti-secretagogue taken for 8 doses over 4 days


Locations(1)

Columbia University Irving Medical Center

New York, New York, United States

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NCT06606327


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