NCT07736079

Brief Summary

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of reproductive age and is strongly associated with insulin resistance and metabolic dysfunction. Preptin is a pancreatic peptide co-secreted with insulin and has been implicated in glucose metabolism and insulin resistance. However, limited data exist regarding serum preptin levels in patients with PCOS. The aim of this study is to evaluate serum preptin levels in women diagnosed with PCOS and to investigate the relationship between preptin levels and insulin resistance parameters.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Jul 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jul 2026Sep 2026

First Submitted

Initial submission to the registry

July 16, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 30, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 16, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

Polycystic Ovary SyndromeInsulin ResistancePreptinBiomarkerHyperandrogenism

Outcome Measures

Primary Outcomes (1)

  • Serum Preptin Concentration

    Serum preptin concentration measured by enzyme-linked immunosorbent assay (ELISA) and expressed in pg/mL.

    Baseline

Secondary Outcomes (1)

  • Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Baseline

Study Arms (2)

PCOS Group

Patients diagnosed with PCOS according to the Rotterdam criteria.

Control Group

Women presenting with similar complaints but not meeting Rotterdam diagnostic criteria for PCOS.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This single-center prospective comparative cross-sectional study will include reproductive-aged women between 18 and 45 years of age who present to the Internal Medicine outpatient clinic with complaints of hirsutism, menstrual irregularity, and hyperandrogenism between June 15, 2026 and September 15, 2026. Participants diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria will constitute the PCOS group. The control group will consist of women with similar clinical complaints who do not meet the Rotterdam diagnostic criteria for PCOS. Only non-obese women with a body mass index (BMI) below 30 kg/m² will be included. Participants with pregnancy, breastfeeding, active infection, chronic systemic disease, rheumatologic or inflammatory disease, diabetes mellitus, hypertension, chronic renal failure, or those receiving treatment for PCOS within the last 6 months will be excluded. All participants will provide written informed consent before enrollment.

You may qualify if:

  • Female participants aged 18-45 years
  • Diagnosis of PCOS according to Rotterdam criteria
  • BMI \<30 kg/m²
  • No PCOS treatment during the previous 6 months
  • Not pregnant or breastfeeding
  • No active infection
  • No rheumatologic or inflammatory disease
  • No chronic systemic disease
  • Written informed consent

You may not qualify if:

  • Age \<18 years or \>45 years
  • Pregnancy or breastfeeding
  • PCOS treatment within the previous 6 months
  • Active infection
  • Rheumatologic or inflammatory disease
  • Hypertension
  • Diabetes mellitus
  • Chronic kidney disease
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin ResistanceHyperandrogenism

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases46, XX Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesAdrenogenital SyndromeMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

gülden ANATACA

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
12 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Specialist Physician

Study Record Dates

First Submitted

July 16, 2026

First Posted

July 30, 2026

Study Start

July 30, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share