Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-27 @ 11:20 PM
Study NCT ID:
NCT06066034
Status:
UNKNOWN
Last Update Posted:
2023-10-04
First Post:
2023-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Serum, Follicular Fluid SREBP1c and LRG1 Levels in PCOS Patients and Correlation With Insulin Resistance
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-29', 'studyFirstSubmitDate': '2023-09-25', 'studyFirstSubmitQcDate': '2023-09-29', 'lastUpdatePostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum LRG1 levels', 'timeFrame': 'one years', 'description': 'pg/ml'}, {'measure': 'follicular fluid LRG1 levels', 'timeFrame': 'one years', 'description': 'pg/ml'}, {'measure': 'Serum SREBP1c levels', 'timeFrame': 'one years', 'description': 'pmol/mL'}, {'measure': 'follicular SREBP1c levels', 'timeFrame': 'one years', 'description': 'pmol/mL'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PCOS', 'Insulin resistance'], 'conditions': ['PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries']}, 'descriptionModule': {'briefSummary': 'Polycystic ovary syndrome (PCOS) is a common reproductive endocrine and metabolic disease that affects 6-20% of women of childbearing age worldwide. Due to changes in modern lifestyles such as low fiber, high fat diets, sedentary lifestyles, smoking, and alcohol consumption, the risk of developing this disease has increased. Its clinical manifestations are heterogeneous, with typical clinical manifestations being oligomenorrhea or amenorrhea, infertility, hirsutism, and polycystic ovarian changes under ultrasound. Women affected by PCOS face significant reproductive challenges, seriously affecting their quality of life and increasing their psychological burden.LRG1 has various regulatory functions, including glucose and lipid metabolism, IR, angiogenesis, organ fibrosis, and inflammation. LRG1 can activate the transcription factor SREBP1 and participate in liver lipid synthesis in obese mice. SREBP1c is the active form of SREBP1. Research has shown that SREBP1c can directly or indirectly participate in the development of IR. Therefore, the investigators speculate that LRG1 may play a certain role in the progression of PCOS through SREBP1c.Understanding the local changes or metabolic characteristics of follicular fluid in patients with PCOS can help elucidate the pathogenesis of PCOS. Therefore, in this study,the investigators aim to detect changes in serum and follicular fluid LRG1, SREBP1c, and related hormone levels, and explore their role in the pathogenesis of PCOS from a systemic and ovarian perspective, providing new ideas for the prevention and treatment of PCOS and IR.', 'detailedDescription': '1. The diagnostic criteria for all participants with polycystic ovary syndrome included in the study were based on the 2003 European Society for Human Reproductive and Embryonic Medicine and American Society for Reproductive Medicine (ESHRE/ASRM) diagnostic criteria in Rotterdam.\n2. Collect basic data of all participants.\n3. After informed consent, all participants were evaluated for insulin sensitivity(the degree of insulin resistance), using the insulin resistance index of the steady-state model. All participants were conducted after signing an informed consent form.\n4. After informed consent, all participants were given fasting venous blood samples in the morning for measuring blood sugar, blood lipids, insulin, C-peptide, glycosylated hemoglobin (HbA1c), and a complete set of sex hormones.\n5. After collecting follicular fluid from all participants, centrifuge at 1000xg for 20 minutes, filter and precipitate, and freeze in a refrigerator at -80 ° C for the determination of LRG1, SREBP1c, and related hormone levels in follicular fluid.\n6. Use SPSS 22.0 statistical software for data analysis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Sterile female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of Polycystic Ovary Syndrome\n\nExclusion Criteria:\n\nCongenital adrenal cortical hyperplasia Adrenocortical carcinoma Cushing syndrome.'}, 'identificationModule': {'nctId': 'NCT06066034', 'briefTitle': 'Changes in Serum, Follicular Fluid SREBP1c and LRG1 Levels in PCOS Patients and Correlation With Insulin Resistance', 'organization': {'class': 'OTHER', 'fullName': 'Zunyi Medical College'}, 'officialTitle': 'Changes in Serum, Follicular Fluid SREBP1c and LRG1 Levels in PCOS Patients and Correlation With Insulin Resistance', 'orgStudyIdInfo': {'id': 'KLLY-2022-041'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal group', 'description': 'With the informed consent of the patient, venous blood was extracted on an empty stomach in the morning, and follicular fluid from multiple follicles was extracted during the 5-9 day menstrual cycle'}, {'label': 'Insulin resistance group', 'description': 'With the informed consent of the patient, venous blood was extracted on an empty stomach in the morning, and follicular fluid from multiple follicles was extracted during the 5-9 day menstrual cycle', 'interventionNames': ['Diagnostic Test: HOMA-IR，ESHRE/ASRM']}, {'label': 'PCOS group', 'description': 'With the informed consent of the patient, venous blood was extracted on an empty stomach in the morning, and follicular fluid from multiple follicles was extracted during the 5-9 day menstrual cycle', 'interventionNames': ['Diagnostic Test: HOMA-IR，ESHRE/ASRM']}, {'label': 'PCOS with insulin resistance group', 'description': 'With the informed consent of the patient, venous blood was extracted on an empty stomach in the morning, and follicular fluid from multiple follicles was extracted during the 5-9 day menstrual cycle', 'interventionNames': ['Diagnostic Test: HOMA-IR，ESHRE/ASRM']}], 'interventions': [{'name': 'HOMA-IR，ESHRE/ASRM', 'type': 'DIAGNOSTIC_TEST', 'description': 'Grouping based on HOMA-IR and the diagnostic criteria of the European Society for Human Reproduction and Embryology and American Society for Reproductive Medicine (ESHRE/ASRM) in Rotterdam in 2003', 'armGroupLabels': ['Insulin resistance group', 'PCOS group', 'PCOS with insulin resistance group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '563000', 'city': 'Zunyi', 'state': 'Guizhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoting Gui, bachelor', 'role': 'CONTACT', 'email': '2302264437@qq.com', 'phone': '+8618882041247'}], 'facility': 'Affiliated Hospital of Zunyi Medical University', 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}], 'centralContacts': [{'name': 'Xin LIao, Dr', 'role': 'CONTACT', 'email': 'liaoxin8618@163.om', 'phone': '+86 135 9520 8618'}], 'overallOfficials': [{'name': 'Fa Sun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guizhou Provincial Health Commission'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gui Xiaoting', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident physician', 'investigatorFullName': 'Gui Xiaoting', 'investigatorAffiliation': 'Zunyi Medical College'}}}}