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临床试验/NCT07163156
NCT07163156Enrolling By Invitation不适用

The Relationship of Prolactin and Inflammatory Markers With Parkinson's Disease Severity: Clinical and Biochemical Evaluation

Çanakkale Onsekiz Mart University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年8月14日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
300
试验地点
1
主要终点
Systemic inflammatory markers

研究概览

简要总结

This cross-sectional observational study aims to evaluate the relationship between serum prolactin levels, peripheral inflammatory markers (NLR, PLR, SII, CRP), and disease severity in patients with Parkinson's disease (PD). A total of at least 300 patients diagnosed with idiopathic PD will be included. Disease severity will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS) and the Modified Hoehn-Yahr staging system. Serum and salivary prolactin levels will be measured using ELISA, while inflammatory markers will be calculated from routine blood tests. The study seeks to clarify whether prolactin and systemic inflammation indicators may serve as non-invasive biomarkers for disease progression and prognosis in PD, with particular emphasis on postmenopausal women.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Diagnosis of idiopathic Parkinson's disease confirmed by a neurologist
  • Both male and postmenopausal female patients
  • Patients able to provide informed consent
  • Clinically stable enough to undergo blood and saliva sampling, as well as neurological assessment

排除标准

  • Premenopausal female patients
  • Patients with secondary or atypical parkinsonism (e.g., drug-induced, vascular, atypical parkinsonian syndromes)
  • Known endocrine disorders affecting prolactin levels (e.g., prolactinoma, pituitary adenoma, hypothyroidism)
  • Use of medications known to alter prolactin secretion (e.g., antipsychotics, dopamine antagonists, estrogen therapy)
  • History of other neurodegenerative diseases (e.g., Alzheimer's, Huntington's)
  • Presence of active infection, chronic inflammatory disease, or malignancy
  • Severe renal, hepatic, or cardiac failure
  • Inability to provide informed consent

结局指标

主要结局

Systemic inflammatory markers

时间窗: 1 year later

NLR, PLR, SII, CRP

Prolactin Level

时间窗: 1 year later

Serum prolactine levels

次要结局

未报告次要终点

研究者

发起方
Çanakkale Onsekiz Mart University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hüseyin Avni Eroğlu

Assoc. Prof.

Çanakkale Onsekiz Mart University

研究点 (1)

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