Actively Recruiting
Graded Insulin Suppression Test P&F
Led by Columbia University · Updated on 2025-12-09
15
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Graded Insulin Suppression Test P&F
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 obtained prior to any study procedures
You will not qualify if you...
- 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
- Diastolic blood pressure < 60 mm Hg or > 100 mm Hg
- Abnormal resting heart rate: < 60 or ≥ 110 bpm
- Sinus bradycardia or tachycardia that has not been considered benign by a physician
- Abnormal screening electrocardiogram including non-sinus rhythm, heart conduction blocks, or unknown ischemic changes
- Hemoglobin A1c ≥ 5.7% or fasting plasma glucose ≥ 100 mg/dL
- Positive pregnancy test in women of childbearing potential
- Positive urine drug screen except for prescribed medications and/or marijuana with agreement to refrain from marijuana use
- Elevated liver enzymes (AST or ALT > 3.0 x upper limit of normal)
- Elevated total bilirubin > 1.25 x upper limit of normal
- Abnormal sodium, potassium, chloride, or bicarbonate levels considered significant
- Reduced kidney function with estimated glomerular filtration rate < 60 mL/min/1.73 m2
- Low hemoglobin (< 10 g/dL) or hematocrit (< 30%)
- Low platelet count (< 100,000/µL)
- Current pregnancy or breastfeeding
- History of prediabetes or diabetes as defined by ADA criteria
- History of gestational diabetes within 5 years
- Use of most antidiabetic medications within 30 days prior to screening except metformin
- History of pancreatic diseases, cardiovascular diseases, or serious heart conditions
- Chronic kidney disease stage 3 or higher
- Advanced or severe liver disease
- Gallstone disease with complications
- Chronic viral illnesses including HBV, HCV, HIV unless eradicated
- Active seizure disorder
- Psychiatric diseases causing functional impairment or requiring certain medications
- Other endocrinopathies such as active Cushing syndrome or adrenal insufficiency
- Venous thromboembolic disease or need for anticoagulation
- Bleeding disorders or significant anemia
- Active malignancy except certain skin and thyroid cancers
- Risk factors for volume overload or hypokalemia
- Use of prescribed medications for excluded conditions within 30 days
- Use of high-dose corticosteroids recently
- Use of beta blockers or certain calcium channel blockers
- Recent bariatric surgery within 6 months
- Clinical concern for alcohol overuse
- Recent severe infection or ongoing febrile illness
- Any condition posing unacceptable risk or interfering with study data
- Known allergies or hypersensitivities to study products or equipment
- Concurrent enrollment in other investigational drug studies within 30 days or 5 half-lives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
J
Joshua R Cook, MD, PhD
CONTACT
I
Ishwari Nagnur
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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