Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
NCT06606327

Diazoxide Suppression Test P&F Study

Led by Columbia University · Updated on 2025-12-11

10

Participants Needed

1

Research Sites

166 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Diazoxide Suppression Test P&F Study

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 bcU/mL)
  • Completion of the graded insulin suppression test (GIST) protocol
  • Written informed consent obtained in English or Spanish
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent in English or Spanish
  • Documented weight loss of  5% in the past 3 months
  • Abnormal blood pressure: systolic < 90 or > 160 mm Hg, diastolic < 60 or > 100 mm Hg
  • Abnormal resting heart rate: < 60 or  110 bpm
  • Non-sinus heart rhythm or conduction blocks on screening electrocardiogram
  • Laboratory evidence of dysglycemia: hemoglobin A1c  5.7% or fasting plasma glucose  100 mg/dL
  • Positive pregnancy test in women of childbearing potential
  • Positive urine drug screen except for prescribed medications and marijuana with agreement to abstain from alcohol
  • Liver function abnormalities exceeding 3 times upper normal limits for transaminases or bilirubin > 1.25 times upper limit
  • Abnormal serum electrolytes or kidney function with estimated glomerular filtration rate < 60 mL/min/1.73 m2
  • Uric acid above normal limits
  • Women currently pregnant or breastfeeding
  • History of prediabetes or diabetes mellitus as defined by American Diabetes Association
  • History of gestational diabetes within 5 years
  • Use of most antidiabetic medications within 30 days prior to screening except metformin
  • Pancreatic diseases including neoplasia, chronic or recent acute pancreatitis
  • Cardiovascular diseases including atherosclerotic disease, angina, myocardial infarction, stroke, peripheral arterial disease, heart failure, severe valvular disease, pulmonary hypertension
  • Chronic kidney disease stage 3 or higher
  • Advanced or severe liver disease or related conditions
  • Active seizure disorder
  • Psychiatric diseases causing functional impairment or requiring certain antipsychotic or other medications
  • Cushing syndrome unless in remission without ongoing treatment
  • Adrenal insufficiency
  • Active malignancy except certain skin and thyroid cancers
  • Risk of volume overload due to medical conditions or medications
  • Use of certain medications related to excluded conditions or corticosteroids over specified doses
  • History of recent weight-loss surgery
  • Alcohol overuse
  • Positive urine drug screen except specified exceptions
  • History of recent severe infection or febrile illness
  • Any other condition deemed unsafe or interfering with study by investigator
  • Known allergy or hypersensitivity to study medications
  • Concurrent enrollment in another investigational drug study within specified time frame

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Columbia University Irving Medical Center

New York, New York, United States, 10032

Actively Recruiting

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Research Team

J

Joshua R Cook, MD, PhD

CONTACT

I

Ishwari Nagnur

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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