Clinical trial · Observational
Bile Acids in Acute Insulin Resistance
Bile Acid and Lipid Metabolism in Patients With Drug-induced Acute Insulin Resistance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor enrollment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AKT Gene Mutation | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Insulin Resistance | — | UNRESOLVED | — |
| MTOR Gene Mutation | — | UNRESOLVED | — |
| PI3K Gene Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug-induced acute insulin resistance due to PI3K inhibitor, AKT inhibitor, or mTOR inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients treated with PI3K/AKT/mTOR inhibitors for cancer
- description
- 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.
- interventionNames
- Drug: Drug-induced acute insulin resistance due to PI3K inhibitor, AKT inhibitor, or mTOR inhibitor
Primary outcomes (2)
- measure
- Ratio of 12-HBA to non-12-HBA
- timeFrame
- 1-2 Months
- description
- 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 7-HCO and 7,12-diHCO will be measured by LC-MS/MS when fasting +/- after 2-hour mixed meal tolerance test.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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 consentReferences
Publications (0)
Data not yet available