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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
Columbia University Irving Medical Center
RECRUITING
New York
Contact Information
Primary
Joshua R Cook, MD, PhD
jrc2175@cumc.columbia.edu
2123056289
Backup
Zachary D Sone
zds2120@cumc.columbia.edu
2123059336
Time Frame
Start Date: 2024-10-23
Estimated Completion Date: 2026-01
Participants
Target number of participants: 10
Treatments
Experimental: Diazoxide
Subjects will take diazoxide oral suspension at 3 mg/kg per dose for 4 days (total of 8 doses)
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Pisa
Leads: Columbia University

This content was sourced from clinicaltrials.gov