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

Summary

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.

Description

Eligibility

Age range

18–70 years

Sex

All

Healthy volunteers

Yes

Interventions

• Drug
  Alpelisib 300 mg

  All participants will ingest one dose of alpelisib 300 mg (2 x 150-mg tablets) at 23:00 on Study Day 1

• Diagnostic Test
  Alpelisib Challenge Test (ACT): Mixed Meal Tolerance Test (MMTT) after taking alpelisib

  All participants will ingest standardized mixed meals of Nestlé BOOST Plus on the morning of Study Day 2 after taking alpelisib the previous evening

• Diagnostic Test
  Hyperglycemic clamp

  All participants will undergo a two-hour hyperglycemic clamp procedure to measure pancreatic insulin reserve on the morning of Study Day 1, prior to taking alpelisib. This procedure involves an infusion of dextrose 20% solution.

Location