Bile Acid and Lipid Metabolism in Patients With Drug-induced Acute Insulin Resistance

AAAU0504

This is a prospective observational study with a primary goal of monitoring changes in circulating bile acid profiles and parameters of glucose and lipid metabolism prior, during, and after cancer treatment with agents that directly impair insulin action: PI3K inhibitors, AKT inhibitors, and mTOR inhibitors. Patients will not receive any cancer treatment specifically for the purposes of this study. Rather, this study will be based on treatment decisions made independently by participants' oncologists according to standard of care or other clinical trial protocol. This study seeks to enroll at least 25 participants each for PI3K inhibitors, mTOR inhibitors and, once available for open-label treatment, AKT inhibitors.

2022-06-10

2026-06-10

2026-06-10

Recruiting

75

Inclusion Criteria: * Age ≥ 18 years * Speaks English and/ or Spanish * Any cancer diagnosis * Planned for treatment with: * PI3K inhibitors * Alpelisib * Inavolisib * Any experimental PI3K inhibitor * AKT inhibitors (if these become available for open-label use during the study course) * Afuresertib * Capivasertib * Ipatasertib * Miransertib * Uposertib * mTOR inhibitors * Everolimus * Sirolimus * Temsirolimus * Signed informed consent Exclusion Criteria: * Known dysglycemia * Known diagnosis of diabetes mellitus * Treatment with glucose-lowering medications at baseline * Insulin * Sulfonylureas or meglitinides * Metformin \>1000mg total daily dose * Thiazolidinediones * SGLT2 inhibitors * GLP-1 receptor agonists * DPP4 inhibitors * Amylin mimetics * Acarbose * Significant biochemical evidence of liver dysfunction on lab tests within 30 days before starting drug that have not fallen to below the following thresholds prior to starting drug * Significant functional or anatomical abnormalities of the small intestine * Use of certain medications at baseline, within 7 days of starting cancer drug * Allergy to cow dairy or soy (only excludes from MMTT, does not exclude from fasting blood draws) * Inability to provide informed consent

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples will be drawn fasting +/- after 2-hour mixed meal tolerance test immediately before and then at 2 and 4 weeks after initiation of PI3K/AKT/mTOR inhibitor treatment. Blood will also be drawn at the end of treatment if treatment concludes within 2 months of starting.'}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}

2023-12-29