Liver Fat and Blood Markers in Teenage Girls With Polycystic Ovary Syndrome and Obesity
Compares liver fat and blood markers in girls with and without polycystic ovary syndrome.
Plain-language title generated from the registry record
Registry title: Biomarker Panel for PCOS-Associated Liver Steatosis in Adolescent Girls (COMPASS-pedPCOS)
Key facts
- Where
- Kayseri, TürkiyeSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for girls aged 10 to 18 in three groups: girls with PCOS and obesity, girls with obesity but without PCOS, and healthy normal-weight girls.
- Age
- 10 to 18 years
- Sex
- Girls and women only
- Disease stage
- PCOS group: both high male-type hormones (hyperandrogenism) and irregular or missing ovulation, with body mass index at or above the 95th percentile. Obesity group: body mass index at or above the 95th percentile, without PCOS features. Healthy group: body mass index between the 5th and 84th percentile.
- Earlier treatment
- Girls cannot have used steroid medicines (corticosteroids), metformin, birth control pills, valproic acid, anti-androgen medicines or other liver-harming medicines in the last three months.
Main reasons for not taking part
- Known liver disease or use of liver-harming medicines
- Other hormone disorders or other causes of high male-type hormones, such as Cushing syndrome or congenital adrenal hyperplasia
- Obesity from a genetic syndrome or a known genetic disorder
- Pregnancy or regular alcohol use
- No consent from a parent or guardian, or no agreement from the child
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 10 and 18 years old?
Source: NCT07731373, who can take part
Where in Türkiye
- University of Health Sciences, Kayseri City HospitalKayseri, TürkiyeContact: Agah B ÖZTÜRK, Principal Investigator, Department of Pediatrics, MDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Kayseri City Hospital
- Trial code
- NCT07731373
- Record updated
- 30 July 2026
- Original description
This single-center, prospective, observational, cross-sectional mechanistic pilot study will evaluate whether polycystic ovary syndrome (PCOS) contributes to hepatic steatosis in adolescent girls independently of adiposity. A total of 150 girls aged 10-18 years will be enrolled into three groups of 50: girls with PCOS and obesity, age- and body mass index-matched girls with obesity but without PCOS, and healthy normal-weight girls. Each participant will undergo a single evaluation comprising anthropometry, clinical and biochemical phenotyping, transient elastography with controlled attenuation parameter and two-dimensional shear wave elastography, and a single venous blood sample.Read full original descriptionShow less
COMPASS-PedPCOS: BMI-Independent Mechanistic Dissection of PCOS-Associated MASLD in Adolescent Girls With Obesity Using an Expanded Biomarker Panel - A Single-Center Pre-Pilot Clinical Study
This single-center, prospective, observational, cross-sectional mechanistic pilot study will evaluate whether polycystic ovary syndrome (PCOS) contributes to hepatic steatosis in adolescent girls independently of adiposity. A total of 150 girls aged 10-18 years will be enrolled into three groups of 50: girls with PCOS and obesity, age- and body mass index-matched girls with obesity but without PCOS, and healthy normal-weight girls. Each participant will undergo a single evaluation comprising anthropometry, clinical and biochemical phenotyping, transient elastography with controlled attenuation parameter and two-dimensional shear wave elastography, and a single venous blood sample.
An extended biomarker panel will be measured by enzyme-linked immunosorbent assay (Fetuin-A, fibroblast growth factor 21, adiponectin, visfatin, cytokeratin-18 M30 and M65, soluble CD163, growth differentiation factor 15, 11-ketotestosterone, and 11beta-hydroxyandrostenedione), together with liquid chromatography-tandem mass spectrometry measurement of testosterone and sex hormone-binding globulin, and genotyping of PNPLA3 rs738409 and HSD17B13 rs72613567. The primary objective is to compare hepatic steatosis and the hepatokine/adipokine profile between the PCOS with obesity group and the adiposity-matched obesity control group, adjusting for body mass index z-score, insulin resistance, and free androgen index. No therapeutic intervention is assigned by the study protocol.
Inclusion: Female, aged 10 to 18 years, with written informed consent from a parent or legal guardian and written assent from the child; Group 1 (PCOS with obesity): both hyperandrogenism and oligo-anovulation required, based on adolescent-adapted Rotterdam criteria; body mass index at or above the 95th percentile; Group 2 (Obesity control): body mass index at or above the 95th percentile, without features of PCOS, matched to Group 1 for age and body mass index; Group 3 (Healthy control): healthy normal-weight girls (body mass index between the 5th and 84th percentile) without chronic disease, hyperandrogenism, or menstrual irregularity.
Exclusion: Use of relevant or hepatotoxic medication within the preceding three months, including corticosteroids, metformin, oral contraceptives, valproic acid, or antiandrogens; Known acute or chronic liver disease (including viral, autoimmune, or Wilson disease) or use of hepatotoxic medication; Endocrine disorders or secondary hyperandrogenism, including Cushing syndrome, hypothyroidism, uncontrolled diabetes mellitus, congenital adrenal hyperplasia, androgen-secreting tumour, or hyperprolactinaemia; Syndromic or monogenic obesity (including Prader-Willi syndrome, Bardet-Biedl syndrome, Alström syndrome, MC4R or LEP variants) or a known genetic disorder; Pregnancy or regular alcohol use; Refusal of consent or assent.