Graded Insulin Suppression Test P&F

Conditions

• Healthy
• Hyperinsulinemia
• Insulin Resistance
• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Insulin regular, 2.0-3.2 mU/m2/min (euinsulinemia) — DRUG
  Insulin infusion to recapitulate euinsulinemia (normal basal insulin)
• Insulin regular, 32 mU/m2/min (hyperinsulinemia) — DRUG
  Insulin infusion to induce hyperinsulinemia for assessment of insulin sensitivity
• Octreotide Acetate, 6-45 ng/kg/min — DRUG
  Suppression of endogenous insulin secretion
• Dextrose 20 % in Water — DRUG
  Production of steady-state plasma glucose (SSPG) reflective of insulin sensitivity at hyperinsulinemia
• Glucagon, 0-0.5 ng/kg/min — DRUG
  Replacement of endogenous glucagon suppressed by octreotide. (Use is optional at the PI's discretion.)

Study Details

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.

Key Dates

Start date

Sep 16, 2024

Status verified

May 2026

Primary completion

Aug 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

15 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Reference (healthy control) group
  Healthy volunteers with body mass index of 18-25 kg/m2, fasting serum insulin \< 10 mU/L, hemoglobin A1c \< 5.7%, and fasting plasma glucose \< 100 mg/dL
• Experimental: Euinsulinemic group
  Volunteers with body mass index of 30-45 kg/m2, fasting serum insulin \< 10 mU/L, hemoglobin A1c \< 5.7%, and fasting plasma glucose \< 100 mg/dL
• Experimental: Hyperinsulinemic group
  Volunteers with body mass index of 30-45 kg/m2, fasting serum insulin \>= 13 mU/L, hemoglobin A1c \< 5.7%, and fasting plasma glucose \< 100 mg/dL

Primary Outcome Measure

Steady-state plasma glucose at euinsulinemia (ESS-G) [ Time Frame: 150-180 minutes during GIST protocol ]

Central Contacts

• Joshua R Cook, MD, PhD
  2123056289
  [email protected]
• Ishwari Nagnur
  2123059336
  [email protected]

Locations (1)

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