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

NCT07480993 | Completed

• 1 other identifier: TABED 1-26-2114
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome (PCOS); Betatrophin; Body Mass Index (BMI); Insulin Resistance

Keywords

Polycystic ovary syndrome; Betatrophin; adolescents; homeostasis model assessment of insulin resistance

Outcome Measures

Primary Outcomes (1)

• Serum betatrophin levels

  picogram/milliliter

  Single measurement at baseline

Secondary Outcomes (4)

• Body mass index

  Single measurement at baseline

• Homeostatic Model Assessment for Insulin Resistance

  Single measurement at baseline

• Fasting glucose

  Single measurement at baseline

• Fasting insulin

  Single measurement at baseline

Study Arms (3)

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

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

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

Interventions

Serum betatrophin levels OTHER

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); Normal-weight PCOS (Group II); Overweight PCOS (Group I)

Eligibility Criteria

• Age: 16 Years - 23 Years
• Gender Eligibility Details: This study enrolled adolescent females only, as it focuses on polycystic ovary syndrome (PCOS), a condition specific to individuals with female reproductive physiology.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Not Valid, 06100, Turkey (Türkiye)

Location

Related Publications (4)

• Wang H, Lai Y, Han C, Liu A, Fan C, Wang H, Zhang H, Ding S, Teng W, Shan Z. The Effects of Serum ANGPTL8/betatrophin on the Risk of Developing the Metabolic Syndrome - A Prospective Study. Sci Rep. 2016 Jun 27;6:28431. doi: 10.1038/srep28431.

  PMID: 27345212 BACKGROUND

• Varikasuvu SR, Panga JR, Satyanarayana MV. Circulating Angiopoietin-like 8 protein (ANGPTL8/Betatrophin) in patients with polycystic ovary syndrome: a systematic review and multi effect size meta-analysis. Gynecol Endocrinol. 2019 Mar;35(3):190-197. doi: 10.1080/09513590.2018.1536736. Epub 2019 Jan 7.

  PMID: 30614305 BACKGROUND

• He Y, Hu W, Yang G, Guo H, Liu H, Li L. Adipose Insulin Resistance and Circulating Betatrophin Levels in Women with PCOS. Biomed Res Int. 2020 Jan 21;2020:1253164. doi: 10.1155/2020/1253164. eCollection 2020.

  PMID: 32076603 BACKGROUND

• Dubey P, Reddy S, Sharma K, Johnson S, Hardy G, Dwivedi AK. Polycystic Ovary Syndrome, Insulin Resistance, and Cardiovascular Disease. Curr Cardiol Rep. 2024 Jun;26(6):483-495. doi: 10.1007/s11886-024-02050-5. Epub 2024 Apr 3.

  PMID: 38568339 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Merve Didem Eşkin Tanrıverdi

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: January 15, 2026
• Primary Completion: March 2, 2026
• Study Completion: March 10, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)