Predictive Effect of TGF-β Combined With INS-PI3K-AKT Signaling Pathway Related Proteins (ADNP, MAP6, Pgc-1α) for POD in Diabetes Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- The correlation between preoperative plasma levels of TGF-β, ADNP, MAP6, PGC-1α and the incidence of delirium within 3 days after operation was analyzed.
研究概览
简要总结
To investigate the relationship between POD, TGF-β and INS-PI3K-AKT signaling pathway related proteins (ADNP, MAP6, PGC-1α) in diabetic patients
详细描述
The study was a two-center, prospective，single blind (blinded to subjects and evaluators)，control, observational clinical study. Participants will collect 3 milliliters of blood from enrolled patients before surgery begins. The collected blood samples were processed and stored in -80℃ refrigerator. All samples were tested TGF-β and INS-PI3K-AKT signaling pathway related proteins (ADNP, MAP6, PGC-1α) by ELISA.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥65 years
- •History of diabetes ≥2 years and Glycated hemoglobin ≥6.5% or no history of diabetes and normal blood glucose
- •The ASA rating is Class I to III
- •The elderly patients of limited thoracic and abdominal tumor surgery
排除标准
- •Refused to participate
- •Previous history of schizophrenia, epilepsy, Parkinson's disease
- •History of alcohol abuse or drug dependence
- •Patients with ASA grade IV and above
- •Severe visual or hearing impairment, can not cooperate with the completion of cognitive function tests
- •Participants in other clinical trials within the last two months
- •Patients with severe arrhythmia or cardiac dysfunction(EF<40%)
- •There was a clear history of neurological and psychiatric problems or long-term use of sedatives or antidepressants
- •History of cerebrovascular disease or brain surgery or trauma
- •Severe liver dysfunction (Child-Pugh class C) or severe renal dysfunction (requiring dialysis)
结局指标
主要结局
The correlation between preoperative plasma levels of TGF-β, ADNP, MAP6, PGC-1α and the incidence of delirium within 3 days after operation was analyzed.
时间窗: 2024-05 to 2026-06
Postoperative delirium (POD) was assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) and the 3-Minute Diagnostic Interview for Confusion Assessment Method-Defined Delirium (3D-CAM). Transforming growth factor-beta (TGF-β), activity-dependent neuroprotective protein (ADNP), microtubule-associated protein 6 (MAP6), and peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) levels were measured using enzyme-linked immunosorbent assay (ELISA) kits.
次要结局
未报告次要终点
研究者
Xie Kangjie
Clinical Professor
Zhejiang Cancer Hospital