Polycystic Ovary Syndrome (PCOS)PREPTIN-PCOSNCT07736079
Evaluation of Serum Preptin Levels in Patients With Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome (PCOS) and Insulin Resistance, run by GÜLDEN ANATACA.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS), Insulin Resistance
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2026to 30 Sep 2026
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- No rheumatologic or inflammatory disease
- No chronic systemic disease
- Written informed consent
Who cannot join
- Age <18 years or >45 years
- Pregnancy or breastfeeding
- PCOS treatment within the previous 6 months
- Active infection
- Rheumatologic or inflammatory disease
- Hypertension
Show all 9Show fewer
- Diabetes mellitus
- Chronic kidney disease
- Refusal to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Serum Preptin Levels and Their Relationship With Insulin Resistance 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.
Read the detailed description
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.
- Keywords
- Polycystic Ovary Syndrome, Insulin Resistance, Preptin, Biomarker, Hyperandrogenism
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Preptin Concentration
Serum preptin concentration measured by enzyme-linked immunosorbent assay (ELISA) and expressed in pg/mL.
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- GÜLDEN ANATACA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, GÜLDEN ANATACA, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736079
- Sponsor's protocol ID
- KAEW2026.05.226
- Acronym
- PREPTIN-PCOS
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Preptin Levels and Their Relationship With Insulin Resistance in Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07736079
- Acronym / sponsor ID
- PREPTIN-PCOS / KAEW2026.05.226
- Keywords
- Polycystic Ovary Syndrome, Insulin Resistance, Preptin, Biomarker, Hyperandrogenism
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- GÜLDEN ANATACAUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- Age <18 years or >45 years
- Pregnancy or breastfeeding
- PCOS treatment within the previous 6 months
- Active infection
- Rheumatologic or inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum Preptin Concentration
Time frame: Baseline
Serum preptin concentration measured by enzyme-linked immunosorbent assay (ELISA) and expressed in pg/mL.
1 secondary outcome
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome (PCOS) and Insulin Resistance, run by GÜLDEN ANATACA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact gülden ANATACA (+905059284244, ganataca@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Preptin Concentration (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.