Actively Recruiting
Human Models of Selective Insulin Resistance: Alpelisib, Part I
Led by Columbia University · Updated on 2026-04-09
32
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
U
University of California, Berkeley
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to understand how the blood sugar-lowering hormone insulin works in healthy adults versus those who are at risk for type 2 diabetes. The study will use a drug called alpelisib, which interferes with insulin's actions in the body, to answer the study's main question: does the liver continue to respond to insulin's stimulation of fat production even when it loses the ability to stop making glucose (sugar) in response to insulin. Researchers will compare the impact of single doses of both alpelisib and placebo (inert non-drug) in random order (like flipping a coin) in study participants. Participants will be asked to stay twice overnight in the hospital, take single doses of alpelisib and placebo (one or the other on each of the two hospital stays), and receive intravenous (into the vein) infusions of non-radioactive "tracer" molecules that allow researchers to measure the production of glucose (sugar) and fats by the liver. Measurements will be done both overnight, while participants are asleep and fasting (not eating or drinking other than water) and while consuming a standardized diet of nutritional beverages during the following day. The objective is to evaluate the effect of lowering insulin levels, while maintaining constant mild hyperglycemia, on plasma glucose and lipid levels.
CONDITIONS
Official Title
Human Models of Selective Insulin Resistance: Alpelisib, Part I
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-70 years
- Able to understand written and spoken English and/or Spanish
- Body mass index of 18-25 kg/m2 for insulin sensitive group or 30-45 kg/m2 for insulin resistant group
- For insulin sensitive group: fasting serum insulin 2 10 BCIU/mL, fasting plasma glucose below 100 mg/dL, hemoglobin A1c below 5.7%, HOMA-IR score below 2.5, and fibrosis-4 score below 1.3
- For insulin resistant group: fasting serum insulin 2 13 BCIU/mL plus prediabetic state (fasting plasma glucose 100-125 mg/dL and/or hemoglobin A1c 5.7-6.4%) and/or HOMA-IR score 2 2.5
You will not qualify if you...
- Unable to provide informed consent in English or Spanish
- Abnormal vital signs including systolic blood pressure below 90 or above 160 mm Hg, diastolic blood pressure below 55 or above 100 mm Hg, or resting heart rate below 55 or above 110 bpm
- Abnormal liver function tests with transaminases or bilirubin above specified limits
- Laboratory evidence of diabetes mellitus with hemoglobin A1c 2 6.5% or fasting plasma glucose 2 126 mg/dL
- Positive pregnancy test, current pregnancy, or breastfeeding
- History of overt diabetes, gestational diabetes in past 5 years, or recent use of most antidiabetic medications except metformin
- Known familial lipid disorders or recent use of certain lipid-lowering drugs
- Significant cardiovascular disease (except uncomplicated hypertension), severe liver disease, certain psychiatric conditions, thromboembolic disease, bleeding disorders, active malignancy except specific skin or thyroid cancers
- Risk of volume overload due to health conditions or medications
- Use of oral or parenteral corticosteroids above specified doses recently
- Recent bariatric surgery within 6 months
- Alcohol overuse based on set weekly limits
- Regular tobacco or nicotine use above set frequency
- Use of illicit drugs except marijuana or prescribed medications
- Recent febrile illness within 30 days
- Any other condition or lab value posing risk or interfering with study
- Known allergies to study components or related materials
- Dietary restrictions incompatible with study medication
- Concurrent enrollment in other investigational drug studies within specified timeframes except prior participation in related studies by the principal investigator
AI-Screening
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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
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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