Association of Changes in NPY, CGRP, SP and TRPV1 With Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- adverse cardiovascular events
研究概览
简要总结
The study was designed to investigate the correlation between perioperative adverse cardiovascular events and the degeneration of sensory nerves in patient diagnosed with type 2 diabetes mellitus, undergoing elective non-cardiac surgery.
详细描述
The study was designed to investigate the correlation between perioperative adverse cardiovascular events and the degeneration of sensory nerves in patient diagnosed with type 2 diabetes mellitus, undergoing elective non-cardiac surgery. Diabetes mellitus and peripheral sensory nerve degeneration will be diagnosed via clinical evaluation. Serum levels of constituent neuropeptides, including neuropeptide Y (NPY), calcitonin and substance P (SP) and calcitonin gene related peptide (CGRP), and transient receptor potential vanilloid 1 (TRPV1), a molecular nociceptor in peripheral sensory nerves will be quantitatively evaluated. The clinical and the biochemical consequence will be compared between the cohorts of diabetic and non-diabetic patients. The differences and the correlations will be analyzed. The results of the study may reveal whether or not the perioperative adverse cardiovascular events in diabetic patients are correlated with degeneration of peripheral sensory nerves and the alterations in the neuropeptides and TRPV1 are potentially applicable for evaluation of the risk of cardiovascular events in perioperative period in diabetic patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main discharge diagnosis is T2DM；
- •Age > 18 years old;
- •No acute complications of diabetes
排除标准
- •T1DM patients;
- •EGFR < 60 ml/min/1.73 m or proteinuria (or both);
- •Patients with history of acute cardiovascular events;
- •Familial hypercholesterolemia or other hereditary lipid metabolism diseases;
- •anti-HIV patients;
- •Patients with serious mental health problems;
- •Patients receiving drugs that can lead to dyslipidemia, such as antipsychotics, corticosteroids, or immunosuppressants;
- •Patients with systemic inflammatory diseases, such as systemic lupus erythematosus;
- •Patient are quitting smoking and severe obesity (BMI>40)
结局指标
主要结局
adverse cardiovascular events
时间窗: Perioperative period
All the pre-, intra- and post-operative adverse cardiovascular events in the patients will be taken into account.
次要结局
- NPY, CGRP, SP and TRPV1(Perioperative period)
研究者
Zheng Guo
Professor and chairman of the Department of Anesthesiology
Second Hospital of Shanxi Medical University