Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-04-02 @ 1:05 AM
Study NCT ID:
NCT04264832
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2020-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Body Fat Distribution and Its Associated Factors in Chinese Women With Polycystic Ovary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 733}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-23', 'studyFirstSubmitDate': '2020-02-07', 'studyFirstSubmitQcDate': '2020-02-07', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body fat content and ratio', 'timeFrame': 'Baseline', 'description': 'Examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan)'}], 'secondaryOutcomes': [{'measure': 'Body mass index (BMI)', 'timeFrame': 'Baseline', 'description': 'Weight in kilograms divided by the square of height in meters, reported in kg/m2'}, {'measure': 'Waist circumference(WC)', 'timeFrame': 'Baseline', 'description': 'Waist circumference（WC）reported in cm, refers to the horizontal circumference along the midpoint of the connection line of the anterior superior iliac crest through the lower costal margin of the calm breathing state when standing. Recumbent position is the abdominal circumference through the girth of the navel.'}, {'measure': 'Hip circumference', 'timeFrame': 'Baseline', 'description': 'Hip circumference reported in cm, and when measured, the legs are upright and closed together, the arms are naturally pendulous, and the tape measure is placed horizontally on the pubic symphysis in front and the gluteus maximus in the back.'}, {'measure': 'Waist-hip ratio (WHR)', 'timeFrame': 'Baseline', 'description': 'Waist-to-hip ratio'}, {'measure': 'Fat content and ratio of trunk', 'timeFrame': 'Baseline', 'description': 'Examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan)'}, {'measure': 'Follicle stimulating hormone (FSH)', 'timeFrame': 'Baseline', 'description': 'Examined with the blood sample'}, {'measure': 'luteinizing hormone (LH)', 'timeFrame': 'Baseline', 'description': 'Examined with the blood sample'}, {'measure': 'Progestin (P)', 'timeFrame': 'Baseline', 'description': 'Examined with the blood sample'}, {'measure': 'Estrogen (E2)', 'timeFrame': 'Baseline', 'description': 'Examined with the blood sample'}, {'measure': 'Prolactin (PRL)', 'timeFrame': 'Baseline', 'description': 'Examined with the blood sample'}, {'measure': 'Androgen(T)', 'timeFrame': 'Baseline', 'description': 'Examined with the blood sample'}, {'measure': 'Androstenedione (A2)', 'timeFrame': 'Baseline', 'description': 'Examined with the blood sample'}, {'measure': 'Glucose', 'timeFrame': 'Baseline', 'description': 'Examined with the blood sample'}, {'measure': 'Insulin', 'timeFrame': 'Baseline', 'description': 'Examined with the blood sample'}, {'measure': 'HOMA-IR', 'timeFrame': 'Baseline', 'description': 'calculation of HOMA-IR: \\[fasting insulin (μU/mL) × fasting glucose (mmol/L)\\] / 22.5)'}, {'measure': 'HOMA- β', 'timeFrame': 'Baseline', 'description': 'calculation of HOMA-β: 20 × fasting insulin (mU/mL) / (fasting plasma glucose (mmol/L) - 3.5) (%)'}, {'measure': 'total cholesterol', 'timeFrame': 'Baseline', 'description': 'examined with the blood sample'}, {'measure': 'triglycerides', 'timeFrame': 'Baseline', 'description': 'examined with the blood sample'}, {'measure': 'high density lipoprotein (HDL)', 'timeFrame': 'Baseline', 'description': 'examined with the blood sample'}, {'measure': 'low density lipoprotein (LDL)', 'timeFrame': 'Baseline', 'description': 'examined with the blood sample examined with the blood sample'}, {'measure': 'β-endorphin', 'timeFrame': 'Baseline', 'description': 'examined with the blood sample'}, {'measure': '5- hydroxytryptamine (5-HT)', 'timeFrame': 'Baseline', 'description': 'examined with the blood sample'}, {'measure': 'Dopamine(DA)', 'timeFrame': 'Baseline', 'description': 'examined with the blood sample'}, {'measure': 'lipometabonomics', 'timeFrame': 'Baseline', 'description': 'examined with the blood sample'}, {'measure': 'bile acid', 'timeFrame': 'Baseline', 'description': 'examined with the blood sample (fasting plasma glucose (mmol/L) - 3.5) (%)'}, {'measure': 'FerrimanGallwey (FG )value', 'timeFrame': 'Baseline', 'description': "To determine changes in women's hairy with FG rating scale (0-36 score), the higher, the worse"}, {'measure': 'short form-36 (SF36)', 'timeFrame': 'Baseline', 'description': 'determine the health quality of life by the questionnaire of SF36 (0-100 score), the higher, the better'}, {'measure': 'Self-Rating Anxiety Scale (SAS)', 'timeFrame': 'Baseline', 'description': 'determine the anxiety level with the questionnaire of SAS (20-100 score), the higher, the worse.'}, {'measure': 'Self-Rating Depress Scale (SDS)', 'timeFrame': 'Baseline', 'description': 'determine the depress level with the questionnaire of SDS (20-100 score), the higher, the worse'}, {'measure': 'Preserved Stress Scale (PSS)', 'timeFrame': 'Baseline', 'description': 'determine the stress level with the questionnaire of SDS (14-56 score), the higher, the worse'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fat distribution', 'insulin resistance', 'negative emotion', 'polycystic ovary syndrome (PCOS)'], 'conditions': ['Polycystic Ovary Syndrome (PCOS)']}, 'referencesModule': {'references': [{'pmid': '40122801', 'type': 'DERIVED', 'citation': 'Yang S, Zhang H, Shi L, Yang Y, Lu Y, Qiu W, Fukuzawa I, Zhou L, Xin X, Ding N, Luo L, Wang W, Zhang H. Menstrual disorder is associated with blood type in PCOS patients: evidence from a cross-sectional survey. BMC Endocr Disord. 2025 Mar 24;25(1):77. doi: 10.1186/s12902-025-01898-0.'}, {'pmid': '39587600', 'type': 'DERIVED', 'citation': 'Zhang H, Qiu W, Zhou P, Shi L, Chen Z, Yang Y, Lu Y, Zhou L, Zhang H, Cheng M, Ye Y, Li R. Obesity is associated with SHBG levels rather than blood lipid profiles in PCOS patients with insulin resistance. BMC Endocr Disord. 2024 Nov 25;24(1):254. doi: 10.1186/s12902-024-01789-w.'}, {'pmid': '36699018', 'type': 'DERIVED', 'citation': 'Zhang H, Wang W, Zhao J, Jiao P, Zeng L, Zhang H, Zhao Y, Shi L, Hu H, Luo L, Fukuzawa I, Li D, Li R, Qiao J. Relationship between body composition, insulin resistance, and hormonal profiles in women with polycystic ovary syndrome. Front Endocrinol (Lausanne). 2023 Jan 9;13:1085656. doi: 10.3389/fendo.2022.1085656. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the body fat distribution in chinese women with polycystic ovary syndrome (PCOS) and the association of those distribution with metabolic parameters, microeconomics, hormone profiles and psychological state.', 'detailedDescription': 'The polycystic ovary syndrome (PCOS) is one of the most common endocrine and metabolic disorders in women of reproductive age. It is also one of the leading causes of anovulatory infertility and secondary amenorrhea, which represent major stress factors in the female life. In the previous studies, the investigators found that PCOS patients showed decreased quality-of-life and increased psychological disturbances compared with healthy controls. Body mass index (BMI) was associated with emotional disorders and physical aspects of quality-of-life and negative emotions were negatively correlated with BMI in PCOS patients.These results prompted that PCOS could be separated into at least two subtypes by the fat content. So the investigators expand the epidemiological investigation for comparing the body composition between the PCOS and the normal women, and finding specific biological indicators in different subtypes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'a cross-sectional study was conducted in women of reproductive age (19- 45 years) from the Peking university third hospital', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 to 45 years\n* For the PCOS group, PCOS diagnosis according to Rotterdam criteria 2003 with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL\n\nExclusion Criteria:\n\n* Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone \\< 3nmol/L) thyroid dysfunction and hyperprolactinemia.\n* Type I diabetes or not well controlled type II diabetes\n* Stage 2 hypertension (resting blood pressure ≥160/100mmHg)\n* Psychiatric diagnoses or using psychiatric medications including antidepressants\n* Pharmacological treatment (cortizone, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months.\n\nThe control group are non- PCOS normal women (age 18-45) and meet the same exclusion criteria."}, 'identificationModule': {'nctId': 'NCT04264832', 'briefTitle': 'Body Fat Distribution and Its Associated Factors in Chinese Women With Polycystic Ovary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Department of Traditional Chinese Medicine (TCM), Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing 100191, China.', 'orgStudyIdInfo': {'id': 'Peking TCM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'observation group', 'description': 'Participants were eligible if they met the Rotterdam diagnostic criteria of polycystic ovary syndrome (PCOS) and meet the inclusion and exclusion criteria , and all study participants received questionnaires and underwent the physical, transvaginal ultrasound and body composition examination. Blood samples were collected for analysis of metabolic markers, metabonomics and hormones.', 'interventionNames': ['Other: Clinical data collection']}, {'label': 'control group', 'description': 'The control group participants are normal women and had no history of any type of diabetes, cardiovascular disease (myocardial infarction, unstable angina, stroke or cardiovascular revascularization), stage 2 hypertension , malignant disease or severe renal or hepatic disease. They accepted the same examinations as the observation group.', 'interventionNames': ['Other: Clinical data collection']}], 'interventions': [{'name': 'Clinical data collection', 'type': 'OTHER', 'description': "Basic characteristics: Participants were carefully characterized with regard to a general health history, a medical history, clinical, demographic and anthropomorphic measurements, skin problems (hirsutism is modified by Ferriman-Gallwey (mF-G) score , global acne score and premature alopecia).\n\nA transvaginal ultrasound scan was performed on every participant during a clinical examination to determine the number of follicles and ovarian volume.\n\nMetabolic and other assessments: General gynecological examination, prolactin, thyroid, androgen, LH, FSH, DA, 5-HT, metabonomics, glucose, insulin, triglyceride (TG), LDL and HDL were determined, OGTT was performed.\n\nQuestionnaires: The perceived stress scale(Chinese 14-item PSS), self-rating anxiety scale (SAS）, self-rating depressive scale(SDS) were used to assess the participants' mental health status. The MOS item short from health survey (SF-36) was used to assess the quality of life .", 'armGroupLabels': ['control group', 'observation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University third hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Haolin Zhang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "We haven't decided whether to share the data"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}