Alpelisib Challenge Test (ACT)

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorColumbia University

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

15 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Columbia University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

University of Pisa

Collaborator