Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-02-27 @ 2:13 AM
Study NCT ID:
NCT03383068
Status:
UNKNOWN
Last Update Posted:
2017-12-26
First Post:
2017-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research of Intensive Metabolic Intervention Before Pregnancy in PCOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020909', 'term': 'Acarbose'}, {'id': 'D000077270', 'term': 'Exenatide'}, {'id': 'D000077403', 'term': 'Orlistat'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D014312', 'term': 'Trisaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-21', 'studyFirstSubmitDate': '2017-11-28', 'studyFirstSubmitQcDate': '2017-12-21', 'lastUpdatePostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of pregnant rate after intensive metabolic intervention', 'timeFrame': 'up to 24 weeks', 'description': 'To compare the pregnant rate of four groups after treatment'}], 'secondaryOutcomes': [{'measure': 'Improvement of obsorbtion rate after intensive metabolic intervention', 'timeFrame': 'up to 24 weeks', 'description': 'To compare the obsorbtion rate of four groups after treatment'}, {'measure': 'Improvement of stillborn foetus rate after intensive metabolic intervention', 'timeFrame': 'up to 24 weeks', 'description': 'To compare the stillborn foetus rate of four groups after treatment'}, {'measure': 'Improvement of hyperandrogenism', 'timeFrame': 'up to 24 weeks', 'description': 'To compare the free androgen index of three groups after treatment'}, {'measure': 'Improvement of intravenous blood glucose from impaired glucose regulation to normal glucose regulation', 'timeFrame': 'up to 24 weeks', 'description': 'To compare the intravenous blood glucose of three groups after treatment'}, {'measure': 'Improvement of triglyceride', 'timeFrame': 'up to 24 weeks', 'description': 'To compare the circulating triglyceride of three groups after treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PCOS', 'imparied glucose tolerance'], 'conditions': ['PCOS', 'Impaired Glucose Tolerance']}, 'descriptionModule': {'briefSummary': "To investigate whether intensive metabolic intervention of PCOS women before pregnancy can improve pregnancy outcome.Besides, the investigators aim to investigate the best therapy strategy of metabolic intervention before pregnancy.The investigators plan to recruit PCOS women at childbearing age. By using acarbose, GLP-1 analogue, berberin et al. the investigators will intervent the participants' metabolic statues for 3 months before pregnancy and to compare outcome in each group.", 'detailedDescription': "To investigate whether intensive metabolic intervention of PCOS women before pregnancy can improve pregnancy outcome.Besides, the investigators aim to investigate the best therapy strategy of metabolic intervention before pregnancy.The investigators plan to recruit PCOS women with IGR / DM not effective of metformin treatment at childbearing age. By using acarbose, GLP-1 analogue, berberin et al. the investigators will intervent the participants' metabolic statues for 3 months before pregnancy and to compare outcome in each group."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PCOS women at Childbearing Age\n* PCOS: Clinical hyperandrogenism and/or hyperandrogenemia, menstrual dysfunction (oligomenorrhea or amenorrhea) and exclusion of other known disorders. PCOS will be diagnosed using the 2003 Rotterdam criteria.\n\nExclusion Criteria:\n\n* Past or present history of a medical disorder or medication known to affect body composition, insulin secretion and sensitivity, or the growth hormone (GH)-insulin-like growth factor 1 (IGF1) axis (eg steroid hormone or thyroid replacement).\n* History of current or past pregnancy\n* Hormonal contraceptive or metformin use within 3 months of enrollment\n* Nonclassical congenital adrenal hyperplasia'}, 'identificationModule': {'nctId': 'NCT03383068', 'acronym': 'PCOS', 'briefTitle': 'Research of Intensive Metabolic Intervention Before Pregnancy in PCOS', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Research of Intensive Metabolic Intervention Before Pregnancy in Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': '[2017]055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'control', 'description': 'metformin(1000-1500mg/d) treated for 6 months, reverse to normal glucose tolerance', 'interventionNames': ['Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'acarbose', 'description': 'metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with acarbose (100mg tid ) for 3 months', 'interventionNames': ['Drug: Acarbose 100 MG']}, {'type': 'EXPERIMENTAL', 'label': 'Exenatide', 'description': 'metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with Exenatide 10μg/bid ) for 3 months', 'interventionNames': ['Drug: Exenatide']}, {'type': 'EXPERIMENTAL', 'label': 'Orlistat', 'description': 'metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with Orlistat(0.12mg/tid ) for 3 months', 'interventionNames': ['Drug: Orlistat']}], 'interventions': [{'name': 'Acarbose 100 MG', 'type': 'DRUG', 'otherNames': ['Acarbose'], 'description': 'for metformin uneffective subjects, using acarbose for 3 months', 'armGroupLabels': ['acarbose']}, {'name': 'Exenatide', 'type': 'DRUG', 'description': 'for metformin uneffective subjects, using Exenatide for 3 months', 'armGroupLabels': ['Exenatide']}, {'name': 'Orlistat', 'type': 'DRUG', 'description': 'for metformin uneffective subjects, using Orlistatfor 3 months', 'armGroupLabels': ['Orlistat']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['METF'], 'description': 'metformin effective subjects,act as control group', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Wei Liu, MD', 'role': 'CONTACT', 'email': 'sue_liuwei@163.com', 'phone': '+86-18918358342'}], 'facility': 'Renji Hospital Department of Endocrinology and Metabolism', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Tao Tao, MD', 'role': 'CONTACT', 'email': 'taotaosh76@163.com', 'phone': '86-13817701776'}], 'overallOfficials': [{'name': 'Tao Tao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RenJi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}