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Clinical Trials/NCT07163156
NCT07163156Enrolling By InvitationNot Applicable

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

Çanakkale Onsekiz Mart University1 site in 1 country300 target enrollmentStarted: August 14, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
300
Locations
1
Primary Endpoint
Systemic inflammatory markers

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Systemic inflammatory markers

Time Frame: 1 year later

NLR, PLR, SII, CRP

Prolactin Level

Time Frame: 1 year later

Serum prolactine levels

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Çanakkale Onsekiz Mart University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hüseyin Avni Eroğlu

Assoc. Prof.

Çanakkale Onsekiz Mart University

Study Sites (1)

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