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Patients treated with PI3K/AKT/mTOR inhibitors for cancer for Insulin Resistance

N/A
Recruiting
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 months
Awards & highlights
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Insulin Resistance
  • Phosphoinositide 3-kinase Mutation
  • AKT Gene Mutation
  • MTOR Mutation
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Insulin resistance
Ratio of 12-HBA to non-12-HBA
Secondary study objectives
Lipids
Surrogate markers of BA signaling

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients treated with PI3K/AKT/mTOR inhibitors for cancerExperimental Treatment1 Intervention
Patients with cancer being treated with PI3K/AKT/mTOR inhibitors will be studied prospectively for the impact of treatment on bile acid metabolism as a function of drug-induced acute insulin resistance. Treatments will be selected by patients' treating oncologist based on standard of care.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,483 Previous Clinical Trials
2,629,920 Total Patients Enrolled
13 Trials studying Insulin Resistance
453 Patients Enrolled for Insulin Resistance
~30 spots leftby Jun 2026