Diazoxide Suppression Test P&F Study

NCT06606327 | Recruiting Phase 1 FDA Drug

• 4 other identifiers: AAAV33703P30DK063608-21K12DK133995K23DK140614
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insulin Resistance; Hyperinsulinemia; Obesity

Keywords

Insulin resistance; Hyperinsulinemia; Type 2 diabetes; Obesity

Outcome Measures

Primary Outcomes (2)

• Fasting plasma glucose

  Plasma glucose level after overnight fast (units: mg/dL)

  Baseline and after 4 days of diazoxide treatment

• Fasting serum insulin

  Serum insulin level after overnight fast (units: µU/mL)

  Baseline and after 4 days of diazoxide treatment

Secondary Outcomes (3)

• Fasting serum C-peptide

  Baseline and after 4 days of diazoxide treatment

• Fasting serum triglyceride

  Baseline and after 4 days of diazoxide treatment

• Fasting plasma free fatty acids (FFA)

  Baseline and after 4 days of diazoxide treatment

Study Arms (1)

Diazoxide

EXPERIMENTAL

Subjects will take diazoxide oral suspension at 3 mg/kg per dose for 4 days (total of 8 doses)

Drug: Diazoxide, 3 mg/kg per dose

Interventions

Diazoxide, 3 mg/kg per dose DRUG

Insulin anti-secretagogue taken for 8 doses over 4 days

Also known as: Proglycem

Diazoxide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 glucose ≥ 100 mg/dL
• Positive qualitative β-hCG (i.e., pregnancy test) in women of childbearing potential (both on the day of screening and on the first day of the DzST, prior to receipt of diazoxide doses)

Sponsors & Collaborators

• University of Pisa: collaborator
• Columbia University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Insulin Resistance; Hyperinsulinism; Obesity; Diabetes Mellitus, Type 2

Interventions

Diazoxide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joshua R Cook, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua R Cook, MD, PhD

CONTACT

2123056289; jrc2175@cumc.columbia.edu

Ishwari Nagnur

CONTACT

2123059336; imn2113@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 23, 2024
• Study Start: October 23, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Scientific data will be shared as soon as possible. Scientific data included in published manuscripts will be available at the time of publication; all other generated scientific data will be shared no later than the end of the award. The study data will be stored in the repository for at least 5 years.
• Access Criteria: To request access of the data, researchers will use the standard processes at Dryad. Given that we seek the widest possible availability, in most cases all that is necessary is obtaining a Dryad account from the repository web site.

Locations

US (1)