Graded Insulin Suppression Test P&F

Study acronym: GIST
StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed Show 6 more changesShow less
    • Final enrollment: 20 participants (planned 15)
    • Primary and study completion dates changed from estimate of Sep 2026 to Oct 13, 2026
    • Interventions: Dextrose 20 % in Water (Drug), Glucagon, 0-0.5 ng/kg/min (Drug), Insulin regular, 2.0-3.2 mU/m2/min (euinsulinemia) (Drug), Insulin… to Dextrose 20 % in Water (Drug), Glucagon, 0-0.5 ng/kg/min (Drug), Insulin regular, 2.0-3.2 mU/m2/min (euinsulinemia) (Drug), Insulin…
    • Eligibility criteria expanded, about 86 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised
  2. Primary and study completion dates: Aug 2026 to Sep 2026
    • Site contact updated
    • Collaborators: 2 to 1
    v8
  3. Secondary endpoints: 2 to 3
    • Primary endpoints revised (2)
    • Study description expanded, about 68 words
    v7
  4. Site contact updated
    • Eligibility criteria expanded, about 5 words
    v6
  5. Primary and study completion dates: Aug 2025 to Aug 2026
    • Eligibility criteria revised
    v5
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  1. Primary endpoints: 4 to 2v4 Show 4 more changesShow less
    • Interventions: Dextrose 20 % in Water (Drug), Insulin regular, 2.0-3.2 mU/m2/min (euinsulinemia) (Drug), Insulin regular, 32 mU/m2/min (hyperinsulinemia)… to Dextrose 20 % in Water (Drug), Glucagon, 0-0.5 ng/kg/min (Drug), Insulin regular, 2.0-3.2 mU/m2/min (euinsulinemia) (Drug), Insulin…
    • Study description expanded, about 6 words
    • Collaborators: 1 to 2
    • Eligibility criteria shortened, about 1 word
  2. Interventions: Dextrose 20 % in Water (Drug), Insulin regular, 3.2 mU/m2/min (euinsulinemia) (Drug), Insulin regular, 32 mU/m2/min (hyperinsulinemia)… to Dextrose 20 % in Water (Drug), Insulin regular, 2.0-3.2 mU/m2/min (euinsulinemia) (Drug), Insulin regular, 32 mU/m2/min (hyperinsulinemia)…v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2024 to Sep 16, 2024
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Columbia University
305 trials monitored
See 27 trials at risk
Diabetes
5,101 trials monitored
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Obesity
3,888 trials monitored
See 157 trials at risk
Type 2 Diabetes
2,236 trials monitored
See 113 trials at risk
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.
Trial Details
NCT Number NCT06592261
Lead Sponsor Columbia University
Collaborators: University of Pisa
Conditions
(from sponsor)		 Insulin Resistance, Hyperinsulinemia, Obesity, Healthy
Related terms Diabetes Mellitus, Type 2, Hyperinsulinism, Insulin Resistance, Obesity
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov