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NCT05571670 · ClinicalTrials.gov registry record
Bile Acids in Acute Insulin Resistance
A clinical trial, sponsored by Columbia University.
- Terminated
- Registry status
- 3
- Enrollment target
NCT05571670: Clinical Trial study, sponsored by Columbia University.
NCT05571670 is a clinical trial that was terminated before completion, run by Columbia University. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05571670 was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- 3 participants
- Enrollment target
Study 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.
Primary Outcome
Insulin resistance is expected to cause a rise in total bile acids, but with 12-alpha-hydroxylated bile acid (12-HBA) species outpacing non-12-alpha-hydroxylated bile acid (non-12-HBA) species, leading to a rise in the 12-HBA:non-12-HBA ratio. This would indicate that insulin resistance per se is sufficient to alter 12-HBA balance, and thus 12-HBA may be a useful therapeutic target for management of the macrovascular complications of insulin resistance. BA profile and levels of BA intermediates
Interventions
- DRUG Drug-induced acute insulin resistance due to PI3K inhibitor, AKT inhibitor, or mTOR inhibitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-06-10 |
| Est. Completion | 2022-06-10 |
Why NCT05571670 stopped before completion
NCT05571670 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 3 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Drug-induced acute insulin resistance due to PI3K inhibitor, AKT inhibitor, or mTOR inhibitor is the first listed.
NCT05571670 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05571670 about?
NCT05571670 is a clinical study titled "Bile Acids in Acute Insulin Resistance". 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 in...
What is the current status of trial NCT05571670?
This trial is currently terminated. The enrollment target is 3 participants. The study started on 2022-06-10. Estimated completion is 2022-06-10.
What interventions are being tested in trial NCT05571670?
The interventions under investigation include: Drug-induced acute insulin resistance due to PI3K inhibitor, AKT inhibitor, or mTOR inhibitor (DRUG).
Who is sponsoring clinical trial NCT05571670?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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