Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-13 @ 5:05 AM
Study NCT ID:
NCT05966792
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-11
First Post:
2023-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SGLT2 Inhibitors in Treating Patients With PCOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-08', 'studyFirstSubmitDate': '2023-07-21', 'studyFirstSubmitQcDate': '2023-07-21', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Menstrual cycles', 'timeFrame': '6 months', 'description': 'annual number of menstrual cycles'}], 'secondaryOutcomes': [{'measure': 'HOMA-IR', 'timeFrame': '6 months', 'description': 'Homeostatic model assessment insulin resistance index'}, {'measure': 'NLRP3', 'timeFrame': '6 months', 'description': 'serum Nod-like receptor protein 3'}, {'measure': 'IL-1β', 'timeFrame': '6 months', 'description': 'serum Interleukin-1 beta'}, {'measure': 'IL-18', 'timeFrame': '6 months', 'description': 'serum Interleukin-18'}, {'measure': 'LH', 'timeFrame': '6 months', 'description': 'luteinizing hormone'}, {'measure': 'FSH', 'timeFrame': '6 months', 'description': 'follicle-stimulating hormone'}, {'measure': 'PRL', 'timeFrame': '6 months', 'description': 'prolactin'}, {'measure': 'E2', 'timeFrame': '6 months', 'description': 'estradiol'}, {'measure': 'P', 'timeFrame': '6 months', 'description': 'progesterone'}, {'measure': 'TT', 'timeFrame': '6 months', 'description': 'total testosterone'}, {'measure': 'AMH', 'timeFrame': '6 months', 'description': 'antimullerian hormone antimullerian hormone antimullerian hormone antimullerian hormone'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'Chronic inflammation is the core of Polycystic ovary syndrome (PCOS), and obesity and overweight further exacerbate the level of inflammation in the peripheral circulation and ovarian tissue in PCOS patients. Metformin is a classic endocrine drug for the treatment of PCOS, but its clinical response rate is only about 40%. Our previous published study (Diabetes Obes Metab, 2022) observed that the new hypoglycemic drug SGLT-2 inhibitor can significantly improve the clinical symptoms of patients with insulin resistance PCOS, and the clinical efficacy is not inferior to metformin, but its specific mechanism of action is not clear. Recent studies have shown that SGLT-2 significantly attenuates the activation of the Nod-like receptor protein 3 (NLRP3) inflammasomes and the secretion of IL-1β in patients with type 2 diabetes mellitus at high risk of cardiovascular disease. Based on the above research background, this project will combine clinical research and mechanism exploration to solve the following two problems:\n\n1. whether SGLT2 inhibitor can further improve the clinical efficacy of PCOS patients compared to metformin;\n2. mechanistic studies further clarify whether SGLT2 inhibitors improve inflammatory symptoms by modulating NLRP3 inflammosomes in the treatment of polycystic ovary syndrome;', 'detailedDescription': 'This clinical study is a prospective, single-center, randomized (1:1) controlled clinical study. The enrollment population is overweight or obese PCOS patients. After signing the informed consent form, patients who meet the inclusion/exclusion criteria will be randomly assigned to the experimental and control groups for treatment in a 1:1 ratio, for a total of 108 patients enrolled.\n\nSubjects randomized to the trial group will receive SGLT-2 inhibitors for 24 weeks.\n\nParticipants randomised to control will receive metformin for 24 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female aged 18-45\n* Meet Rotterdam criteria\n* BMI≥20kg/m2\n\nExclusion Criteria:\n\n* Treatment with any additional medications that might impede the trial, including GLP-1 RAs, metformin, pioglitazone, contraceptives, or traditional Chinese medicine within the past 3 months\n* Pregnancy or lactation\n* Mental illness\n* Malignant tumors\n* Chronic kidney disease or severe liver dysfunction\n* Inflammatory bowel disease\n* Involvement in other research programs within the past 3 months'}, 'identificationModule': {'nctId': 'NCT05966792', 'briefTitle': 'SGLT2 Inhibitors in Treating Patients With PCOS', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'The Clinical Efficacy and Mechanism of SGLT2 Inhibitors Treating Polycystic Ovary Syndrome by Modulating the Nod-like Receptor Protein 3 Inflammasome', 'orgStudyIdInfo': {'id': 'SGLT2i in PCOS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SGLT2 inhibitors', 'description': 'Intervention with henggliflozin (10mg qd) for 6 months', 'interventionNames': ['Drug: SGLT2 inhibitors']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'metformin', 'description': 'Intervention with metformin (500mg bid) for 6 months', 'interventionNames': ['Drug: metformin']}], 'interventions': [{'name': 'SGLT2 inhibitors', 'type': 'DRUG', 'description': 'Sodium-glucose cotransporters inhibitors (SGLT2i) are novel hypoglycemic drugs with unique hypoglycemic mechanisms, which are completely independent of islet β-cell function or insulin sensitivity. Previous studies have shown that SGLT2i may improve IR by inhibiting glucotoxicity, reducing body weight, reducing inflammation, improving islet β-cell function, and reducing oxidative stress.', 'armGroupLabels': ['SGLT2 inhibitors']}, {'name': 'metformin', 'type': 'DRUG', 'description': 'Metformin is a classic drug for the treatment of polycystic ovary syndrome, which can improve the degree of insulin resistance in PCOS patients.', 'armGroupLabels': ['metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Tenth People'S Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Manna Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai 10th People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, principal investigator, clinical professor', 'investigatorFullName': 'Zhang Manna', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}