Prolactin, Inflammation, and Parkinson's Severity

NCT ID: NCT07163156

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-14

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Idiopathic Parkinson Disease Prolactin Prolactin Levels Inflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Parkinson's Disease Patients

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Çanakkale Onsekiz Mart University

OTHER

Sponsor Role lead

Responsible Party

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Hüseyin Avni Eroğlu

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Çanakkale Onsekiz Mart University

Çanakkale, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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NOT YET

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

COMU-FNN-1

Identifier Type: -

Identifier Source: org_study_id

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