An observational study in Polycystic Ovary Syndrome (PCOS) and Insulin Resistance, sponsored by GÜLDEN ANATACA. Not yet recruiting. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by GÜLDEN ANATACA · Observational
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.
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.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's planned enrollment of 60 is below the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →GÜLDEN ANATACA is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with PCOS according to the Rotterdam criteria.
Women presenting with similar complaints but not meeting Rotterdam diagnostic criteria for PCOS.
Serum Preptin Concentration
Serum preptin concentration measured by enzyme-linked immunosorbent assay (ELISA) and expressed in pg/mL.
Time frame: Baseline
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
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.
Time frame: Baseline
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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