Polycystic Ovary Syndrome (PCOS)NCT07480993
Serum Betatrophin Levels in Normal-Weight and Overweight Adolescents With PCOS
An observational study of Polycystic Ovary Syndrome (PCOS) and Betatrophin, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 23 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS), Betatrophin, Body Mass Index (BMI)
- What is being tested?
- Serum betatrophin levels
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2026to 10 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 23 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Not Valid, 06100
About this study
Official title: 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.
- Being tested
- Serum betatrophin levels
- Keywords
- Polycystic ovary syndrome, Betatrophin, adolescents, homeostasis model assessment of insulin resistance
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum betatrophin levelsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Serum betatrophin levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum betatrophin levels
picogram/milliliter
Measured: Single measurement at baseline
Secondary outcomes (4)
Body mass index
kg/m²
Measured: Single measurement at baseline
Homeostatic Model Assessment for Insulin Resistance
HOMA-IR was calculated using the formula: (Fasting insulin [µIU/mL] × Fasting glucose [mg/dL]) / 405 to assess insulin resistance.
Measured: Single measurement at baseline
Fasting glucose
mg/dL
Measured: Single measurement at baseline
Fasting insulin
µIU/mL
Measured: Single measurement at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start15 Jan 2026
- Primary completion2 Mar 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Didem Eşkin Tanrıverdi, Ankara City Hospital Bilkent
- Investigators
- Merve Didem Eşkin Tanrıverdi, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480993
- Sponsor's protocol ID
- TABED 1-26-2114
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are available which may be shared in necessary conditions.
Publications
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.
PubMed 27345212Varikasuvu 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.
PubMed 30614305He 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.
PubMed 32076603Dubey 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.
PubMed 38568339
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Betatrophin Levels in Normal-Weight and Overweight Adolescents With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07480993
- Acronym / sponsor ID
- TABED 1-26-2114
- Keywords
- Polycystic ovary syndrome, Betatrophin, adolescents, homeostasis model assessment of insulin resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 18 Mar 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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Overweight PCOS (Group I) | – | Other: Serum betatrophin levelsAdolescent 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. |
| Normal-weight PCOS (Group II) | – | Other: Serum betatrophin levelsAdolescent 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. |
| Healthy Controls (Group III) | – | Other: Serum betatrophin levelsAge-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. |
Who may qualify
- Ages
- 16 to 23 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- Cardiovascular diseases including hypertension
- Type 1 or type 2 diabetes mellitus
- Morbid obesity
- Primary adrenal insufficiency
- Uterine fibroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum betatrophin levelsMeasurement 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). | Other | Healthy Controls (Group III), Normal-weight PCOS (Group II), Overweight PCOS (Group I) |
Primary outcome
Serum betatrophin levels
Time frame: Single measurement at baseline
picogram/milliliter
4 secondary outcomes
Body mass index
Time frame: Single measurement at baseline
Homeostatic Model Assessment for Insulin Resistance
Time frame: Single measurement at baseline
Fasting glucose
Time frame: Single measurement at baseline
Fasting insulin
Time frame: Single measurement at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 27345212Wang 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.
- Background: PubMed 30614305Varikasuvu 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.
- Background: PubMed 32076603He 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.
- Background: PubMed 38568339Dubey 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.
- Individual participant dataSharing planned: No. IPD are available which may be shared in necessary conditions.
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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. This study is not recruiting at the moment.
Merve Didem Eşkin Tanrıverdi principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome (PCOS) and Betatrophin, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum betatrophin levels (time frame: Single measurement at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07480993, which also lists 4 linked publications.
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 18 Mar 2026.