Graded Insulin Suppression Test for Insulin Resistance
This study aims to understand how insulin controls blood sugar in people with and without insulin resistance. Researchers want to find out how much insulin the body truly needs to keep blood sugar normal. You might be eligible if you are 18-65 years old, have a BMI between 18-25 or 30-45 kg/m2, and have specific fasting insulin levels (normal or high). The study involves a single-day visit where you will receive intravenous (into the vein) infusions of octreotide acetate (to stop your body's own insulin production), insulin regular at two different levels, and dextrose 20% in water (sugar). Glucagon may also be given. Blood sugar levels will be checked frequently. The study will measure your steady-state plasma glucose (blood sugar levels when stable) at both low and high insulin levels to see how your body responds. The study plans to enroll 15 participants, but its current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 15 participants. It is not specified if it is randomized, blinded, or what phase it is in.
- What's involved
- You would participate in a one-day study visit. During this visit, you will receive intravenous infusions and have your blood sugar levels checked frequently.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at 150-180 minutes and 270-300 minutes during the GIST protocol, indicating a short-term follow-up during the study visit.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06592261
Graded Insulin Suppression Test P&F
Recruiting
PHASE1Ages 18–65InterventionalBasic scienceColumbia UniversityInvestigator-initiated
~15 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:Insulin regular, 2.0-3.2 mU/m2/min (euinsulinemia)Insulin regular, 32 mU/m2/min (hyperinsulinemia)Octreotide Acetate, 6-45 ng/kg/minDextrose 20 % in WaterGlucagon, 0-0.5 ng/kg/min
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Steady-state plasma glucose at euinsulinemia (ESS-G)
Measured over 150-180 minutes during GIST protocol
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Joshua R Cook, MD, PhD · PRINCIPAL_INVESTIGATOR · Columbia University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Body mass index of 18-25 and 30-45 kg/m2
Able to understand written and spoken English and/or Spanish
Fasting euinsulinemia (fasting serum insulin of 4-10 μU/mL) for reference group or hyperinsulinemia (fasting serum insulin ≥ 13 μU/mL) for hyperinsulinemic group on screening labs
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.
Known, documented history, at the time of screening, of any of the following medical conditions:
Pancreatic pathology, including but not limited to: Pancreatic neoplasia (unless appropriately evaluated and considered benign and not producing hormones), Chronic pancreatitis, History of acute pancreatitis within the past 5 years
Cardiovascular diseases (N.B. uncomplicated hypertension is not exclusionary)
Atherosclerotic cardiovascular disease
Stable or unstable angina
Myocardial infarction
Ischaemic or hemorrhagic stroke
Peripheral arterial disease (claudication)
Use of dual antiplatelet therapy (aspirin + P2Y12 inhibitor)
History of percutaneous coronary intervention
Heart rhythm abnormalities (non-sinus)
Congestive heart failure of any New York Heart Association class
Severe valvular heart disease (e.g., aortic stenosis)
Pulmonary hypertension
Chronic kidney disease, Stage 3 or higher (estimated glomerular filtration rate \< 60 mL/min/1.73 m2), of any cause
Advanced or severe liver disease, including but not limited to:
Advanced liver fibrosis, as determined by non-invasive testing
Cirrhosis of any etiology
Autoimmune hepatitis or other rheumatologic disorder affecting the liver
Biliopathy (e.g., progressive sclerosing cholangitis, primary biliary cholangitis)
Hepatocellular carcinoma
Infiltrative disorders (e.g., sarcoidosis, hemochromatosis, Wilson disease)
Gallstone disease, including:
Biliary colic (active)
History of acute cholecystitis not treated with cholecystectomy
History of other gallstone complications (e.g., pancreatitis, cholangitis)
Chronic viral illness (N.B. diagnosis based only on medical history and not by laboratory confirmation)
Hepatitis B virus (HBV), unless previously successfully eradicated with antiviral drugs that have been discontinued for at least 30 d prior to screening
Hepatitis C virus (HCV) infection, unless previously successfully eradicated with antiviral drugs that have been discontinued for at least 30 d prior to screening
Human immunodeficiency virus (HIV) infection
Active seizure disorder (including controlled with antiepileptic drugs)
Psychiatric diseases causing functional impairment that:
Are or have been decompensated within 1 year of screening, and/or
Require use of anti-dopaminergic antipsychotic drugs associated with significant weight gain/metabolic dysfunction (e.g., clozapine, olanzapine), monoamine oxidase inhibitors, tricyclic antidepressants, or lithium
Other endocrinopathies:
Cushing syndrome (okay if considered in remission after treatment, provided that no exogenous corticosteroids or other ongoing treatment are required)
Adrenal insufficiency
Primary aldosteronism
Venous thromboembolic disease (deep vein thrombosis or pulmonary embolism) or any required use of therapeutic anticoagulation
Bleeding disorders, including due to anticoagulation, or significant anemia
Active malignancy, or hormonally active benign neoplasm, except allowances for:
Non-melanoma skin cancer
Differentiated thyroid cancer (AJCC Stage I only)
Clinical concern for increased risk of volume overload, including due to medications and/or heart/liver/kidney problems, as listed above
Clinical concern for increased risk of hypokalemia, including low potassium on screening labs (i.e., below lower limit of normal), use of certain medications, or any medical conditions listed above
Use of prescribed medications used for any of the indications in the preceding list of excluded conditions, or their use within 30 d prior to screening, except allowances for:
Use of drugs prescribed for indications other than the exclusionary diagnoses/purposes listed above (e.g., antiepileptic drugs used for non-seizure indications, ACEi/ARB used for uncomplicated hypertension rather than for congestive heart failure, etc.). Note, as above, that antidiabetic drugs except metformin within 30 d of screening are excluded.
Oral or parenteral corticosteroids (at greater than prednisone 5 mg daily, or equivalent) for more than 3 days within the previous 30 days; topical and inhaled formulations are permitted.
Beta blockers or non-dihydropyridine calcium channel blockers (verapamil or diltiazem)
History of certain weight-loss (bariatric) surgery, including:
Roux-en-Y gastric bypass
Biliopancreatic diversion
Restrictive procedures (lap band, sleeve gastrectomy) performed within the past 6 months
Clinical concern for alcohol overuse, including recent documented history during screening and/or participant report of regularly consuming more than 2 drinks per day for males or 1 drink per day for females.
History of severe infection or ongoing febrile illness within 14 days of screening
Any other disease, condition, or laboratory value that, in the opinion of the investigator, would place the participant at an unacceptable risk and/or interfere with the analysis of study data.
Known allergy/hypersensitivity to any component of the medicinal product formulations, foods, IV infusion equipment, plastics, adhesive or silicone, history of infusion site reactions with IV administration of other medicines, or ongoing clinically important allergy/hypersensitivity as judged by the investigator.
Concurrent enrollment in another clinical study of any investigational drug therapy within 30 days prior to screening or within 5 half-lives of an investigational agent, whichever is longer.
Exclusion
Unable to provide informed consent in English or Spanish
Unwillingness to use only bedpan or urinal to void or to refrain from non-emergent mobile device use during the GIST
Documented weight loss of ≥ 5% of baseline within the previous 6 months
Systolic blood pressure \< 90 mm Hg or \> 160 mm Hg, and/or
Diastolic blood pressure \< 60 mm Hg or \> 100 mm Hg
Abnormal resting heart rate: \< 60 or ≥ 110 bpm
Sinus brady or tachycardia that has been worked up and considered benign by the recruit's personal physician may be permitted at the PI's discretion
Abnormal screening electrocardiogram (or if on file, performed within previous 90 d):
Non-sinus rhythm
Heart conduction blocks
Previously unknown ischaemic changes that persist on repeat EKG:
ST elevations
T-wave inversions in a vascular distribution
Hemoglobin A1c ≥ 5.7%, and/or
Fasting plasma glucose ≥ 100 mg/dL
Positive qualitative β-hCG (i.e., pregnancy test) in women of childbearing potential
Positive urine drug screen, except for lawfully prescribed medications and/or marijuana, provided that participant agrees to refrain from marijuana use during the period that they refrain from alcohol.
Transaminases (AST or ALT) \> 3.0 x the upper limit of normal
Total bilirubin \> 1.25 x the upper limit of normal
Abnormal sodium, potassium, chloride, or bicarbonate levels that are considered potentially significant according to the clinical judgment of the PI.
Creatinine equating to estimated glomerular filtration rate \< 60 mL min-1 1.73 m-2
Hemoglobin \< 10 g/dL or hematocrit \< 30%
Platelet count \< 100,000/μL
Women currently pregnant, measured by serum and/or urine β-hCG
Women currently breastfeeding
History of having met any of the American Diabetes Association's definitions of prediabetic state during adulthood or diabetes mellitus (i.e., overt diabetes) at any time:
Hemoglobin A1c ≥ 5.7%, or rapid rise in documented HbA1c values causing clinical concern for evolving insulin deficiency
Plasma glucose ≥ 100 mg/dL after 8-h fast
Plasma glucose of ≥ 140 mg/dL at 2 h after ingestion of a 75-g glucose load
Random plasma glucose ≥ 200 mg/dL associated with typical hyperglycemic symptoms, diabetic ketoacidosis, or hyperglycemic-hyperosmolar state
History of gestational diabetes mellitus within the previous 5 years
Use of most antidiabetic medications within the 30 days prior to screening
Excluded: thiazolidinediones, sulfonylureas, meglitinides, DPP4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, amylin mimetics, acarbose, insulin
What this trial measures
- Steady-state plasma glucose at euinsulinemia (ESS-G)150-180 minutes during GIST protocol
Plasma glucose level at steady state while insulin infusion rate is 2 mU/m2/min (units: mg/dL)
- Steady-state plasma glucose at hyperinsulinemia (HSS-G)270-300 minutes during GIST protocol
Plasma glucose level at steady state while insulin infusion rate is 32 mU/m2/min and glucose infusion rate is 267 mg/m2/min, reflective of insulin sensitivity (units: mg/dL)