Graded Insulin Suppression Test P&F

Summary

The goal of this study is to learn about how the hormone insulin controls blood sugar in a variety of people. The main question it aims to answer is about how much insulin the body actually needs to maintain a normal blood sugar level. Participants will be asked to come in for a one-day study visit in which they will undergo a "graded insulin suppression test" ("GIST"). The GIST involves intravenous (into the vein) infusions of octreotide, a medication that turns off the body's own production of insulin, as well as replacement of insulin at two different levels (low and high), with or without replacement of glucagon, and glucose (sugar). The study investigators will check blood sugar levels every few minutes during the procedure to determine the effect of the two different insulin levels. This study will evaluate the GIST in both healthy volunteers and those at higher risk for type 2 diabetes.

Conditions

• Insulin Resistance
• Hyperinsulinemia
• Obesity
• Healthy

Interventions

DRUG

Insulin regular, 2.0-3.2 mU/m2/min (euinsulinemia)

Insulin infusion to recapitulate euinsulinemia (normal basal insulin)

DRUG

Insulin regular, 32 mU/m2/min (hyperinsulinemia)

Insulin infusion to induce hyperinsulinemia for assessment of insulin sensitivity

DRUG

Octreotide Acetate, 6-45 ng/kg/min

Suppression of endogenous insulin secretion

DRUG

Dextrose 20 % in Water

Production of steady-state plasma glucose (SSPG) reflective of insulin sensitivity at hyperinsulinemia

DRUG

Glucagon, 0-0.5 ng/kg/min

Replacement of endogenous glucagon suppressed by octreotide. (Use is optional at the PI's discretion.)

Sponsors & Collaborators

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

  collaborator NIH

• University of Pisa

  collaborator OTHER

• Columbia University

  lead OTHER

Principal Investigators

• Joshua R Cook, MD, PhD · Columbia University

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-09-16

Primary Completion

2026-08-31

Completion

2026-08-31

FDA Drug

Yes

Countries

• United States

Study Locations