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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

Outcome Measure
Measure Description
Time Frame
Serum betatrophin levels
Time Frame: Single measurement at baseline
picogram/milliliter
Single measurement at baseline

Secondary Outcome Measures

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

Ankara City Hospital Bilkent

Investigators

  • 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)

January 15, 2026

Primary Completion (Actual)

March 2, 2026

Study Completion (Actual)

March 10, 2026

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 14, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 14, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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