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Enrolling by invitationNCT07163156PRIPSUpdated Sep 9, 2025

Prolactin, Inflammation, and Parkinson's Severity

An observational study in Idiopathic Parkinson Disease, Prolactin and Prolactin Levels, sponsored by Çanakkale Onsekiz Mart University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-09.

Sponsored by Çanakkale Onsekiz Mart University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Idiopathic Parkinson Disease
  • Prolactin
  • Prolactin Levels
  • Inflammation
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 300 is above the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Çanakkale Onsekiz Mart University is the lead sponsor of 50 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

The study population will consist of at least 300 adult patients (≥18 years) diagnosed with idiopathic Parkinson's disease who are followed at the Neurology Department of Çanakkale Onsekiz Mart University. Both male and postmenopausal female patients will be included. Participants must be clinically stable and able to undergo neurological evaluation, serum and salivary prolactin testing, and routine laboratory investigations. Patients with atypical or secondary parkinsonism, endocrine disorders affecting prolactin levels, active infection, chronic inflammatory disease, or malignancy will be excluded.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 1

    Parkinson's Disease Patients

06

What researchers measure

Primary outcomes

  1. Systemic inflammatory markers

    NLR, PLR, SII, CRP

    Time frame: 1 year later

  2. Prolactin Level

    Serum prolactine levels

    Time frame: 1 year later

07

Study locations

1 site
  • Çanakkale Onsekiz Mart University
    Çanakkale, Merkez 17020, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07163156
Lead sponsor
Çanakkale Onsekiz Mart University
Responsible party
Hüseyin Avni Eroğlu (Assoc. Prof., Çanakkale Onsekiz Mart University) — Principal investigator
First posted
Sep 9, 2025
Start date
Aug 14, 2025
Primary completion
Dec 2025 (estimated)
Completion
Jun 2026 (estimated)
Last update
Sep 9, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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