Clinical trial

Biomarker Panel for PCOS-Associated Liver Steatosis in Adolescent Girls (COMPASS-pedPCOS)

Opening soon · Not applicable · 1 countries · Registry ID NCT07731373

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age10 Years to 18 Years

SexFemale

Healthy volunteersAccepted

ConditionPolycystic Ovary Syndrome (PCOS), Metabolic Dysfunction-Associated Steatotic Liver Disease, Pediatric Obesity, Hyperandrogenism, Insulin Resistance Syndrome

Full registry criteria

Inclusion Criteria: * 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 Criteria: * 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. * Use of relevant or hepatotoxic medication within the preceding three months, including corticosteroids, metformin, oral contraceptives, valproic acid, or antiandrogens. * Pregnancy or regular alcohol use. * Refusal of consent or assent.

Treatments and study arms

Extended Serum Biomarker and Hormonal Panel

Diagnostic Test

A single fasting venous blood sample is obtained at the study visit. Enzyme-linked immunosorbent assay measurement of Fetuin-A, fibroblast growth factor 21, adiponectin, visfatin, cytokeratin-18 M30, cytokeratin-18 M65, soluble CD163, growth differentiation factor 15, 11-ketotestosterone and 11beta-hydroxyandrostenedione is performed. Total testosterone and sex hormone-binding globulin are measured by liquid chromatography-tandem mass spectrometry. Routine biochemistry and hormonal profiling are performed from the same sample. Observational only; no therapeutic agent is administered.

Liver Elastography with Controlled Attenuation Parameter

Diagnostic Test

Hepatic steatosis and liver stiffness are assessed non-invasively at the same study visit. Vibration-controlled transient elastography with controlled attenuation parameter yields attenuation (dB/m) and stiffness (kPa) values; two-dimensional shear wave elastography provides an independent stiffness estimate. Predefined validity criteria are applied to all acquisitions. No sedation, contrast agent or ionizing radiation is used; the procedure is observational.

Targeted Genotyping of PNPLA3 rs738409 and HSD17B13 rs72613567

Genetic

Genomic DNA is isolated from the same single venous blood sample; no additional venipuncture is required. TaqMan allelic discrimination assays are used for genotyping of PNPLA3 rs738409 and HSD17B13 rs72613567. Genotype call rate and Hardy-Weinberg equilibrium are reported. Genotyping is performed for research purposes only; results are not used to guide clinical management.

Primary outcomes

Hepatic Steatosis Measured by Controlled Attenuation Parameter (CAP)Day 1 (single study visit)

Controlled attenuation parameter obtained during vibration-controlled transient elastography, compared between girls with PCOS and obesity and adiposity-matched girls with obesity, and across all three study groups, with adjustment for body mass index z-score, homeostatic model assessment of insulin resistance, and free androgen index. Unit of measure: dB/m.

Serum Fetuin-A ConcentrationDay 1 (single study visit)

Serum Fetuin-A measured by enzyme-linked immunosorbent assay and compared across the three study groups with adjustment for body mass index z-score, homeostatic model assessment of insulin resistance, and free androgen index. Unit of measure: µg/mL.

Serum Fibroblast Growth Factor 21 (FGF-21) ConcentrationDay 1 (single study visit)

Serum FGF-21 measured by enzyme-linked immunosorbent assay and compared across the three study groups with adjustment for body mass index z-score, homeostatic model assessment of insulin resistance, and free androgen index. Unit of measure: pg/mL.

Serum Adiponectin ConcentrationDay 1 (single study visit)

Serum adiponectin measured by enzyme-linked immunosorbent assay and compared across the three study groups with adjustment for body mass index z-score, homeostatic model assessment of insulin resistance, and free androgen index. Unit of measure: µg/mL.

Serum Visfatin ConcentrationDay 1 (single study visit)

Serum visfatin measured by enzyme-linked immunosorbent assay and compared across the three study groups with adjustment for body mass index z-score, homeostatic model assessment of insulin resistance, and free androgen index. Unit of measure: ng/mL.

Study locations

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University of Health Sciences, Kayseri City Hospital🌐 Kayseri, Turkey (Türkiye)

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Agah B ÖZTÜRK, Principal Investigator, Department of Pediatrics, MDContact

Email · Call +90 352 315 77 00