RecruitingPhase 1NCT06592261

Graded Insulin Suppression Test P&F

Human Models of Selective Insulin Resistance: Graded Insulin Suppression Test (GIST) Pilot & Feasibility Study


Sponsor

Columbia University

Enrollment

15 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a procedure called the Graded Insulin Suppression Test (GIST) to measure how well insulin controls blood sugar (insulin resistance) in people who are either lean or overweight. It is a research test comparing people who have normal vs. high insulin levels while fasting. **You may be eligible if...** - Your BMI is either 18–25 (healthy weight) or 30–45 (obese range) - You are able to understand written and spoken English or Spanish - Your fasting insulin level is either 4–10 µU/mL (normal group) or 13 µU/mL or higher (high insulin group) **You may NOT be eligible if...** - You have pre-diabetes or diabetes (HbA1c of 5.7% or above, or elevated fasting glucose) - Your blood pressure is very high or very low outside normal ranges - You have abnormal heart rhythms or ECG findings - You are unwilling to use a bedpan or avoid phone use during the test - You have lost more than 5% of your body weight in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

Insulin infusion to recapitulate euinsulinemia (normal basal insulin)

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

Insulin infusion to induce hyperinsulinemia for assessment of insulin sensitivity

DRUGOctreotide Acetate, 6-45 ng/kg/min

Suppression of endogenous insulin secretion

DRUGDextrose 20 % in Water

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

DRUGGlucagon, 0-0.5 ng/kg/min

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


Locations(1)

Columbia University Irving Medical Center

New York, New York, United States

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NCT06592261


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