Human Models of Primary Hyperinsulinemia: Diazoxide Suppression Test (DzST) Pilot & Feasibility Study
Columbia University
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.
Description
The investigators are interested in determining to what extent the hyperinsulinemia commonly associated with insulin resistance (IR) in those at risk for type 2 diabetes (T2D) is a primary phenomenon, rather than merely a secondary, compensatory response to IR. The study hypothesis is that some people with obesity and hyperinsulinemia exhibit a primary, non-compensatory hyperinsulinemia that may foment IR and its dysmetabolic sequelae. If this were the case, lowering insulin levels should not result in a proportional rise in blood glucose as might be expected if the hyperinsulinemia truly were…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * Unable to provide i…
Interventions
- DrugDiazoxide, 3 mg/kg per dose
Insulin anti-secretagogue taken for 8 doses over 4 days
Location
- Columbia University Irving Medical CenterNew York, New York