Lung Cancer
Conditions
Brief summary
The goal of this clinical trial is evaluate the effect of pioglitazone compared with placebo on skeletal muscle insulin sensitivity in subjects with cancer and cachexia.
Interventions
The dose of pioglitazone will not exceed 45 mg once daily. Pioglitazone dose will titrate progressively over the first three weeks.
DRUGPlacebo
Placebo will have the same appearance as the active drug.
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Documented histologic or cytologic diagnosis of non-small-cell lung cancer or gastrointestinal cancer that is locally advanced and inoperable or metastatic (e.g., spread to distant organs) * Cachexia defined by Fearon criteria * Insulin resistance syndrome, defined with the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) * Ability to provide written informed consent, willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures * Provide written approval by a qualified healthcare professional * Allow the collection and storage of biospecimens and data for future use
Exclusion criteria
* Prior diagnosis of type 2 diabetes * Prior or current thiazolidinedione (TZD) therapy * Known hypersensitivity to TZD * New York Heart Association (NYHA) class I-IV heart failure * History of or actively treated bladder cancer * Current use of CYP2C inhibitor (e.g., gemfibrozil) or CYP2C inducer (e.g., rifampin) * Inadequate hepatic function * Currently pregnant, breastfeeding, or planning to become pregnant within the next 16 weeks * Contraindications to magnetic resonance imaging (e.g., implanted cardiac device, cochlear implant) * Any other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in skeletal muscle insulin sensitivity | Baseline, Week 12 | Quantified using hyperinsulinemic-euglycemic clamp |
Countries
United States
Outcome results
None listed