About this trial
The goal of this study is to test a potentially easier method for measuring how much insulin a person is capable of producing than the current gold-standard method, the "hyperglycemic clamp." Participants will come in for a two-day (overnight) visit in which they will first undergo a "hyperglycemic clamp," in which they receive an intravenous (into the vein) infusion of glucose (sugar) in order to measure the maximum amount of insulin their body produces in response. They will then consume a series of three standardized meals throughout the rest of the day. At 23:00, they will take a single dose of alpelisib, a drug that interferes within insulin's actions in the body. Then, the following morning, they will undergo a "Mixed Meal Tolerance Test" in which they consume a standardized liquid nutritional beverage and have blood drawn periodically before and during the test.
Eligibility criteria
Qualifiers
Adults aged 18-70 years
Able to understand wrifen and spoken English and/or Spanish
Body mass index of 18-45 kg/m2 (or 18-42 kg/m2 for those of Asian ancestry)
For Lean group: BMI 18.0-24.9 kg/m2 (or 18.0-22.9 kg/m2 for those of Asian ancestry)
Disqualifiers
Inability to provide informed consent in English or Spanish
Unwillingness to fast (except water) for up to 18 hours
Unwillingness not to get out of bed and to use bedpan/urinal to void for up to 15 hours
Documented weight change of ≥ 5.0% of baseline within the previous 3 months
Trial design
Treatments tested in this trial
- Alpelisib 300 mg
- Alpelisib Challenge Test (ACT): Mixed Meal Tolerance Test (MMTT) after taking alpelisib
- Hyperglycemic clamp
Treatment groups
Sponsors and collaborators
Columbia University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Pisa
Collaborator