ClinicalTrials.gov record NCT07736079
Evaluation of Serum Preptin Levels in Patients With Polycystic Ovary Syndrome
Evaluation of Serum Preptin Levels and Their Relationship With Insulin Resistance in Patients With Polycystic Ovary Syndrome
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a prospective, observational case-control study comparing serum preptin concentrations between women diagnosed with PCOS and women without PCOS. At baseline participants have blood tests to measure preptin and fasting glucose and insulin for insulin-resistance assessment. The study seeks to explore whether preptin is associated with insulin resistance. Target duration listed is 12 weeks.
What it is studying. The study is testing whether serum preptin concentrations differ between women with PCOS and women without PCOS, and whether preptin levels are related to measures of insulin resistance.
What the researchers hope to learn. To add evidence about serum preptin concentrations in women with PCOS and to examine the peptide's association with insulin resistance. The study aims to improve understanding of metabolic mechanisms in PCOS and to assess whether preptin could be considered as a biomarker for further research.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
You would give written informed consent and attend a baseline clinic visit. At that visit you would have a fasting blood draw to measure serum preptin and fasting glucose and insulin (these are used to calculate HOMA‑IR). The registry lists the main measurements at baseline and does not describe other procedures, questionnaires, or additional follow‑up visits.
How the study is structured. Single-center, prospective observational case-control study. Participants are grouped as PCOS or control based on diagnosis; no treatments are assigned. At baseline blood is drawn to measure serum preptin (by ELISA) and to obtain fasting glucose and insulin values used to calculate HOMA-IR.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Polycystic Ovary Syndrome (PCOS); Insulin Resistance. Does it apply to my diagnosis?
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
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Important dates
- Study start
- Jul 30, 2026 (estimated)
- Primary completion
- Sep 30, 2026 (estimated)
- Study completion
- Sep 30, 2026 (estimated)
- Target enrollment
- 60 participants (estimated)
- Last updated on registry
- Jul 30, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- GÜLDEN ANATACA
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- gülden ANATACA 📞 +905059284244 ✉ ganataca@yahoo.com
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.
Terms used on this page · explanations by MedicalUpdates.ai
- Written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- biomarker
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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