Human Models of Selective Insulin Resistance: Alpelisib, Part I

PHASE1RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

April 24, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

December 31, 2026

Conditions
Insulin ResistancePrediabetic StateOverweight and ObesityNon-Alcoholic Fatty Liver Disease
Interventions
DRUG

Alpelisib 300 mg

All participants will ingest one dose of alpelisib 300 mg (2 x 150-mg overencapsulated tablets) on one of two study admissions.

DRUG

Placebo

All participants will ingest one dose of placebo (2 overencapuslated doses of microcrystalline cellulose) on one of two study admissions.

DRUG

[1-13C] sodium acetate

All participants will receive continuous infusions of \[1-13C\] sodium acetate for up to 23 hours on both study visits in order to quantify de novo lipogenesis (DNL). (non-experimental)

DRUG

[6,6-2H2] D-glucose

All participants will receive continuous infusions of \[6,6-2H2\] D-glucose for up to 15 hours on both study visits in order to quantify de novo lipogenesis (DNL). (non-experimental)

DIETARY_SUPPLEMENT

Nestlé BOOST Plus

All participants will ingest standardized mixed meals of Nestlé BOOST Plus on Study Day 1 and then smaller portions hourly x 8 hours on Study Day 2 of each study visit. (non-experimental)

Trial Locations (1)

10032

RECRUITING

Columbia University Irving Medical Center, New York

All Listed Sponsors
collaborator

University of California, Berkeley

OTHER

collaborator

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

NIH

collaborator

Stanford University

OTHER

lead

Columbia University

OTHER