The Neuroendocrine Effects of Pioglitazone in Patients With Cancer and Cachexia
Phase 2
Active, not recruiting
- Conditions
- Lung Cancer
- Interventions
- Drug: Placebo
- Registration Number
- NCT05919147
- Lead Sponsor
- Pennington Biomedical Research Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pioglitazone Pioglitazone 45 mg - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change in skeletal muscle insulin sensitivity Baseline, Week 12 Quantified using hyperinsulinemic-euglycemic clamp
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
How does pioglitazone modulate PPAR-γ signaling to improve skeletal muscle insulin sensitivity in lung cancer cachexia?
What is the comparative efficacy of pioglitazone versus standard-of-care cachexia treatments in lung cancer patients?
Which biomarkers (e.g., PPAR-γ expression, IL-6, or TNF-α levels) predict response to pioglitazone in cachectic lung cancer patients?
What are the potential adverse events of pioglitazone in cachexia patients, and how do they compare to placebo in NCT05919147?
Are there synergistic combination therapies involving pioglitazone and anabolic agents for cancer cachexia treatment?
Trial Locations
- Locations (1)
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States
Pennington Biomedical Research Center🇺🇸Baton Rouge, Louisiana, United States