๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-18

Alpelisib Challenge Test (ACT) (NCT07778524)

Alpelisib Challenge Test (ACT) for Assessment of Pancreatic ฮฒ-Cell Reserve, Pilot & Feasibility Study

๐ŸŸก Not Yet Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Columbia University

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Columbia University Irving Medical Center โ€” New York, New York

Age range: 18 Years to 70 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Columbia University Irving Medical Center โ€” New York, New York

๐Ÿ“ž Contact the Study Coordinator

Phone: (212) 305-2663

Email: jrc2175@cumc.columbia.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—