Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 4:01 AM
Study NCT ID:
NCT07480993
Status:
COMPLETED
Last Update Posted:
2026-03-18
First Post:
2026-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Betatrophin Levels in Normal-Weight and Overweight Adolescents With PCOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-03-14', 'studyFirstSubmitQcDate': '2026-03-14', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum betatrophin levels', 'timeFrame': 'Single measurement at baseline', 'description': 'picogram/milliliter'}], 'secondaryOutcomes': [{'measure': 'Body mass index', 'timeFrame': 'Single measurement at baseline', 'description': 'kg/m²'}, {'measure': 'Homeostatic Model Assessment for Insulin Resistance', 'timeFrame': 'Single measurement at baseline', 'description': 'HOMA-IR was calculated using the formula: (Fasting insulin \\[µIU/mL\\] × Fasting glucose \\[mg/dL\\]) / 405 to assess insulin resistance.'}, {'measure': 'Fasting glucose', 'timeFrame': 'Single measurement at baseline', 'description': 'mg/dL'}, {'measure': 'Fasting insulin', 'timeFrame': 'Single measurement at baseline', 'description': 'µIU/mL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polycystic ovary syndrome', 'Betatrophin', 'adolescents', 'homeostasis model assessment of insulin resistance'], 'conditions': ['Polycystic Ovary Syndrome (PCOS)', 'Betatrophin', 'Body Mass Index (BMI)', 'Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '27345212', 'type': 'BACKGROUND', 'citation': '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': '30614305', 'type': 'BACKGROUND', 'citation': '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': '32076603', 'type': 'BACKGROUND', 'citation': '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': '38568339', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '23 Years', 'minimumAge': '16 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'genderDescription': 'This study enrolled adolescent females only, as it focuses on polycystic ovary syndrome (PCOS), a condition specific to individuals with female reproductive physiology.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adolescent females aged 16-23 years\n* Post-menarche status\n* Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria (for Groups I and II)\n* Age-matched healthy females without PCOS for control group (Group III).\n* Ability and willingness to provide informed consent/assent\n* Willingness to comply with study procedures and blood sample collection\n\nExclusion Criteria:\n\n* Cardiovascular diseases including hypertension\n* Type 1 or type 2 diabetes mellitus\n* Morbid obesity\n* Primary adrenal insufficiency\n* Uterine fibroids\n* Thyroid dysfunctions including Hashimoto thyroiditis and Grave's disease\n* Hepatic dysfunctions\n* Renal insufficiency\n* Genetic disorders in chromosome constitution or karyotype analysis including monosomy X, trisomy X and gene mutations as BMP15, FMR I, POFIB, and GDF9\n* Neurologic diseases\n* Psychiatric disorders\n* 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\n* History of any malignancy\n* History of exposure to chemotherapeutic agents or radiotherapy"}, 'identificationModule': {'nctId': 'NCT07480993', 'briefTitle': 'Serum Betatrophin Levels in Normal-Weight and Overweight Adolescents With PCOS', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Evaluation of Serum Betatrophin Levels in Normal-Weight and Overweight Adolescents With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'TABED 1-26-2114'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Overweight PCOS (Group I)', 'description': '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.', 'interventionNames': ['Other: Serum betatrophin levels']}, {'label': 'Normal-weight PCOS (Group II)', 'description': '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.', 'interventionNames': ['Other: Serum betatrophin levels']}, {'label': 'Healthy Controls (Group III)', 'description': '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.', 'interventionNames': ['Other: Serum betatrophin levels']}], 'interventions': [{'name': 'Serum betatrophin levels', 'type': 'OTHER', 'description': '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).', 'armGroupLabels': ['Healthy Controls (Group III)', 'Normal-weight PCOS (Group II)', 'Overweight PCOS (Group I)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'state': 'Not Valid', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Merve Didem Eşkin Tanrıverdi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara City Hospital Bilkent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD are available which may be shared in necessary conditions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Merve Didem Eşkin Tanrıverdi', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}