Serum Betatrophin Levels in Normal-Weight and Overweight Adolescents With PCOS

March 14, 2026 updated by: Merve Didem Eşkin Tanrıverdi, Ankara City Hospital Bilkent

Evaluation of Serum Betatrophin Levels in Normal-Weight and Overweight Adolescents With Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder in adolescents and women of reproductive age and is frequently associated with insulin resistance and an increased risk of metabolic complications. The mechanisms underlying these metabolic abnormalities are not fully understood. Betatrophin (angiopoietin-like protein 8, ANGPTL8) is a liver- and adipose tissue-derived protein involved in lipid and glucose metabolism and has been suggested to be associated with insulin resistance and metabolic stress. This study aims to evaluate serum betatrophin levels in adolescents with PCOS compared with age-matched healthy controls. Adolescents with PCOS will also be categorized according to body mass index (BMI) as normal-weight or overweight to investigate the potential influence of body weight. Additionally, the relationships between betatrophin levels and anthropometric parameters, hormonal profiles, and markers of insulin resistance will be examined.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Not Valid
      • Ankara, Not Valid, Turkey (Türkiye), 06100
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Study population includes a total of 90 participants. The study cohort comprised 30 participants with a BMI ≥25 kg/m² (Group I) and 30 participants with a BMI <25 kg/m² (Group II), all fulfilling the Rotterdam criteria for polycystic ovary syndrome (PCOS), in addition to 30 age-matched healthy controls (Group III).

Description

Inclusion Criteria:

  • Adolescent females aged 16-23 years
  • Post-menarche status
  • Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria (for Groups I and II)
  • Age-matched healthy females without PCOS for control group (Group III).
  • Ability and willingness to provide informed consent/assent
  • Willingness to comply with study procedures and blood sample collection

Exclusion Criteria:

  • Cardiovascular diseases including hypertension
  • Type 1 or type 2 diabetes mellitus
  • Morbid obesity
  • Primary adrenal insufficiency
  • Uterine fibroids
  • Thyroid dysfunctions including Hashimoto thyroiditis and Grave's disease
  • Hepatic dysfunctions
  • Renal insufficiency
  • Genetic disorders in chromosome constitution or karyotype analysis including monosomy X, trisomy X and gene mutations as BMP15, FMR I, POFIB, and GDF9
  • Neurologic diseases
  • Psychiatric disorders
  • Autoimmune diseases or syndromes including Addison's disease, autoimmune syndromes, scleroderma, Sjogren's syndrome, myasthenia gravis, inflammatory bowel diseases, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus and familial Mediterranean fever
  • History of any malignancy
  • History of exposure to chemotherapeutic agents or radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Overweight PCOS (Group I)
Adolescent females diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria, with a body mass index (BMI) ≥25 kg/m². Participants have not received prior medical or surgical treatment for PCOS and do not have chronic diseases such as diabetes, cardiovascular, thyroid, or rheumatologic disorders.
Other: Serum betatrophin levels
Measurement of venous blood serum level of betatrophin by ELISA method. These measurements were performed in all groups (Overweight PCOS, Normal-weight PCOS, and Healthy Controls).
Normal-weight PCOS (Group II)
Adolescent females diagnosed with PCOS according to the Rotterdam criteria, with a BMI <25 kg/m². Participants have not received prior medical or surgical treatment for PCOS and do not have chronic diseases including diabetes, cardiovascular, thyroid, or rheumatologic disorders.
Other: Serum betatrophin levels
Measurement of venous blood serum level of betatrophin by ELISA method. These measurements were performed in all groups (Overweight PCOS, Normal-weight PCOS, and Healthy Controls).
Healthy Controls (Group III)
Age-matched adolescent females without PCOS or any chronic endocrine, metabolic, or systemic diseases. Participants have not received prior medical or surgical treatment affecting metabolic or hormonal status.
Other: Serum betatrophin levels
Measurement of venous blood serum level of betatrophin by ELISA method. These measurements were performed in all groups (Overweight PCOS, Normal-weight PCOS, and Healthy Controls).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum betatrophin levels
Time Frame: Single measurement at baseline
picogram/milliliter
Single measurement at baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body mass index
Time Frame: Single measurement at baseline
kg/m²
Single measurement at baseline
Homeostatic Model Assessment for Insulin Resistance
Time Frame: Single measurement at baseline
HOMA-IR was calculated using the formula: (Fasting insulin [µIU/mL] × Fasting glucose [mg/dL]) / 405 to assess insulin resistance.
Single measurement at baseline
Fasting glucose
Time Frame: Single measurement at baseline
mg/dL
Single measurement at baseline
Fasting insulin
Time Frame: Single measurement at baseline
µIU/mL
Single measurement at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Merve Didem Eşkin Tanrıverdi, Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TABED 1-26-2114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD are available which may be shared in necessary conditions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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