Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-28 @ 1:31 AM
Study NCT ID:
NCT04508634
Status:
UNKNOWN
Last Update Posted:
2023-04-12
First Post:
2020-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating Obese PCOS Patients With LSG vs. Met
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': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'laparoscopic sleeve gastrectomy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2020-08-07', 'studyFirstSubmitQcDate': '2020-08-10', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HOMA-IR', 'timeFrame': '3 months', 'description': 'Insulin resistance index'}, {'measure': 'Screening of metabolites in plasma concentration in fasting condition', 'timeFrame': '3 months', 'description': 'The investigators will perform metabolites to identify the changes that may give rise to the disease.'}, {'measure': 'Screening of transcriptome profile in plasma concentration in fasting condition', 'timeFrame': '3 months', 'description': 'The investigators will perform transcriptome profile to identify the changes that may give rise to the disease.'}, {'measure': 'Screening of Microbiome in faeces', 'timeFrame': '3 months', 'description': 'The investigators will perform Microbiome to identify the changes that may give rise to the disease.'}], 'secondaryOutcomes': [{'measure': 'menstrual cycles', 'timeFrame': '3 months', 'description': 'menstrual frequency'}, {'measure': 'Gonadotropin level', 'timeFrame': '3 months', 'description': 'LH(IU/L) , FSH (IU/L),'}, {'measure': 'testosterone', 'timeFrame': '3 months', 'description': 'total testosterone (nmol/L), testosterone (nmol/L)'}, {'measure': 'SHBG level', 'timeFrame': '3 months', 'description': 'SHBG (nmol/L).'}, {'measure': 'FINS', 'timeFrame': '3 months', 'description': 'fasting insulin (IU/L)'}, {'measure': 'TC', 'timeFrame': '3 months', 'description': 'Total cholesterol (mmol/L)'}, {'measure': 'TG', 'timeFrame': '3 months', 'description': 'Triglycerides (mmol/L)'}, {'measure': 'HDL-c', 'timeFrame': '3 months', 'description': 'high-density lipoprotein cholesterol (mmol/L)'}, {'measure': 'LDL-c', 'timeFrame': '3 months', 'description': 'low-density lipoprotein cholesterol (mmol/L)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Sleeve gastrectomy was an effective threapy for severe obesity patients. This study will evaluate the clinical efficacy of sleeve gastrectomy for obese patients with PCOS. Mealwhile, the specific mechanism of sleeve gastrectomy for improving obese patients with PCOS will be explored through multi-group analysis.'}, '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 ≥ 28 kg /m2.\n\nExclusion Criteria:\n\n* Women who are pregnant or have a pregnancy plan within six months;\n* Women who are reluctant to undergo metabolic surgery;\n* Congenital adrenocortical hyperplasia;\n* Hyperprolactinemia;\n* Hyperthyroidism or hypothyroidism;\n* Abnormal liver function (≥ 3 times of the upper limit of normal range); abnormal · Rrenal function (GFR\\<60ml/min/1.73m2);\n* Adrenal or ovarian tumors secreting androgens;\n* Used contraceptives, metformin, GLP-1RA, pioglitazone and contraceptives in the last 3 month.'}, 'identificationModule': {'nctId': 'NCT04508634', 'briefTitle': 'Treating Obese PCOS Patients With LSG vs. Met', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Comparison of the Clinical Efficacy of Laparoscopic Sleeve Gastrectomy and Metformin in the Treatment of Obese Patients With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'LSG vs. Met in PCOS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'laparoscopic sleeve gastrectomy', 'description': 'laparoscopic sleeve gastrectomy', 'interventionNames': ['Procedure: laparoscopic sleeve gastrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin Group', 'description': 'Metformin Group', 'interventionNames': ['Drug: Metformin Pill']}], 'interventions': [{'name': 'laparoscopic sleeve gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['Sleeve Operation'], 'description': 'laparoscopic sleeve gastrectomy', 'armGroupLabels': ['laparoscopic sleeve gastrectomy']}, {'name': 'Metformin Pill', 'type': 'DRUG', 'description': 'Metformin 1000mg bid', 'armGroupLabels': ['Metformin Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Tenth People' Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Shen Qu, Dr', 'role': 'STUDY_CHAIR', 'affiliation': "Shang hai Tenth People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Endocrinology & Metabolism', 'investigatorFullName': 'Zhang Manna', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}