NCT05919147进行中（未招募）2 期
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Neuroendocrine Effects of Pioglitazone in Patients With Cancer and Cachexia
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in skeletal muscle insulin sensitivity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pioglitazone
Experimental
干预措施: Pioglitazone 45 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in skeletal muscle insulin sensitivity
时间窗: Baseline, Week 12
Quantified using hyperinsulinemic-euglycemic clamp
次要结局
未报告次要终点
研究者
Steven Heymsfield
Professor
Pennington Biomedical Research Center
研究点 (1)
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