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NCT Number: NCT07736079

Evaluation of Serum Preptin Levels in Patients With Polycystic Ovary Syndrome

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.

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Key information

About this study

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders affecting women of reproductive age and is characterized by reproductive, endocrine, and metabolic abnormalities. Although the etiology of PCOS is multifactorial, insulin resistance and compensatory hyperinsulinemia are recognized as key mechanisms contributing to both the reproductive and metabolic manifestations of the syndrome. These metabolic disturbances increase the long-term risk of impaired glucose tolerance, type 2 diabetes mellitus, dyslipidemia, metabolic syndrome, and cardiovascular disease.

Preptin is a 34-amino acid peptide derived from the E-peptide region of pro-insulin-like growth factor II (pro-IGF-II) and is co-secreted with insulin by pancreatic β-cells. Experimental and clinical studies suggest that preptin enhances glucose-mediated insulin secretion and may participate in the regulation of glucose homeostasis. Elevated circulating preptin concentrations have been reported in several metabolic disorders associated with insulin resistance, including obesity and type 2 diabetes mellitus. However, its role in the pathophysiology of PCOS remains poorly understood, and the available evidence is limited and inconsistent.

The present study has been designed to investigate whether serum preptin concentrations differ between women with PCOS and women without PCOS and to explore the potential association between preptin and insulin resistance. By evaluating this novel metabolic peptide, the study seeks to improve understanding of the metabolic mechanisms underlying PCOS and to determine whether preptin may have potential utility as a biomarker associated with the syndrome.

Despite increasing interest in novel metabolic biomarkers, the clinical significance of preptin in PCOS remains unclear because only a limited number of studies have evaluated this peptide in women with PCOS. Furthermore, published findings are inconsistent regarding the relationship between circulating preptin concentrations and insulin resistance. The present study aims to provide additional evidence regarding serum preptin concentrations in women with PCOS and to explore their association with metabolic parameters. A better understanding of preptin biology may contribute to the identification of novel biomarkers involved in the metabolic pathophysiology of PCOS and may support future diagnostic and therapeutic research.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Serum Preptin Concentration

    Time frame: Baseline

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

Secondary outcomes

  1. Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: Baseline

    Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) score. HOMA-IR is a continuous index of insulin resistance calculated from fasting plasma glucose and fasting insulin concentrations. Higher values indicate greater insulin resistance. There is no fixed minimum or maximum score.

Study contacts

Contact information is provided by the study sponsor or research team.

gülden ANATACA

CONTACT

[email protected]

+905059284244

Sponsors and collaborators

Lead sponsor

GÜLDEN ANATACA

Other

Registry information

Official study title

Evaluation of Serum Preptin Levels and Their Relationship With Insulin Resistance in Patients With Polycystic Ovary Syndrome

Acronym: PREPTIN-PCOS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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