Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-03-02 @ 11:09 PM
Study NCT ID:
NCT02446834
Status:
COMPLETED
Last Update Posted:
2022-10-17
First Post:
2015-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research of Intensive Lifestyle Intervention for PCOS Patients With IGT
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': 'D000097789', 'term': 'Glucagon-Like Peptide-1 Receptor Agonists'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D020909', 'term': 'Acarbose'}], 'ancestors': [{'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014312', 'term': 'Trisaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-13', 'studyFirstSubmitDate': '2015-05-06', 'studyFirstSubmitQcDate': '2015-05-13', 'lastUpdatePostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes of Islet β-cell functions from baseline', 'timeFrame': 'up to 12 weeks', 'description': 'Insulin and blood glucose levels'}], 'secondaryOutcomes': [{'measure': 'Incretin', 'timeFrame': 'up to 12 weeks', 'description': 'GLP-1, glucagon，GIP, PYY'}, {'measure': 'Intra-abdominal fat distribution', 'timeFrame': 'up to 12 weeks', 'description': 'measured by MRI'}, {'measure': 'Sex Hormone', 'timeFrame': 'up to 12 weeks', 'description': 'testosterone, estradiol, LH, and FSH'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PCOS', 'intensive lifestyle intervention', 'IGT', 'drugs treatment'], 'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'Compare the efficacy between intensive lifestyle intervention and drugs (GLP-1 Receptor Agonists, metformin and acarbose) for PCOS patients with early onset diabetes in their metabolic and reproductive abnormalities treatment; clear the treatment effect and mechanism of intensive lifestyle intervention to PCOS.', 'detailedDescription': 'We designed a non randomized control study to compare the efficacy between intensive lifestyle intervention and drugs (GLP-1 Receptor Agonists, metformin and acarbose) for PCOS patients with early onset diabetes in their metabolic and reproductive abnormalities treatment We planed to enroll 48 patients.Overweight and obese PCOS patients with newly diagnosed IGT; PCOS diagnosis based on 1990 NIH criteria. Overweight / obesity diagnostic criteria according to WHO-WPR. IGT diagnostic criteria according to 1998 WHO diagnostic criteria. Except for serious complications (cardiovascular events and recent significant kidney or lung disease within 3 months), and had high blood pressure (\\>160/100mmHg), blood sugar and high blood lipids (glycated hemoglobin\\> 11%, triglycerides \\>600 mg/dl).\n\nThen we devided the 48 patients into 4 groups: intensive lifestyle intervention group, GLP-1 group, metformin group and acarbose group, and each group 12 samples. Each group use specific treatment(showed as the group name) 3 months. Before and after the intervention, the blood samples would be collected to Glucose, Insulin, GLP-1, Glucagon, sex hormones, Blood chemistry for liver and kidney function ect, as well as the image examinations.\n\nWe will compare the data of each patient, finally identify the treatment effect and mechanism of intensive lifestyle intervention to PCOS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight and obese PCOS patients with newly diagnosed IGT; PCOS diagnosis based on 1990 NIH criteria. Overweight / obesity diagnostic criteria according to WHO-WPR. IGT diagnostic criteria according to 1998 WHO diagnostic criteria.\n\nExclusion Criteria:\n\n* Except for serious complications (cardiovascular events and recent significant kidney or lung disease within 3 months), and had high blood pressure (\\>160/100mmHg), blood sugar and high blood lipids (glycated hemoglobin\\> 11%, triglycerides \\>600 mg/dl).'}, 'identificationModule': {'nctId': 'NCT02446834', 'briefTitle': 'Research of Intensive Lifestyle Intervention for PCOS Patients With IGT', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Research of Intensive Lifestyle Intervention for Overweight PCOS Patients With Impaired Glucose Tolerance in Their Metabolic and Reproductive Abnormalities Treatment', 'orgStudyIdInfo': {'id': '[2015]018K'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intensive lifestyle intervention', 'description': '3 months intensive lifestyle intervention, including low GI diet and exercise.', 'interventionNames': ['Behavioral: intensive lifestyle intervention']}, {'type': 'EXPERIMENTAL', 'label': 'GLP-1 Receptor Agonists', 'description': '3 months GLP-1 Receptor Agonists treatment', 'interventionNames': ['Drug: GLP-1 Receptor Agonists']}, {'type': 'EXPERIMENTAL', 'label': 'metformin', 'description': '3 months metformin treatment', 'interventionNames': ['Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'acarbose', 'description': '3 months acarbose treatment', 'interventionNames': ['Drug: Acarbose']}], 'interventions': [{'name': 'intensive lifestyle intervention', 'type': 'BEHAVIORAL', 'otherNames': ['group 1'], 'description': '3 months low GI diet and exercise', 'armGroupLabels': ['intensive lifestyle intervention']}, {'name': 'GLP-1 Receptor Agonists', 'type': 'DRUG', 'otherNames': ['group 2'], 'description': 'Use GLP-1 Receptor Agonists 3 months to treat PCOS', 'armGroupLabels': ['GLP-1 Receptor Agonists']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['group 3'], 'description': 'Use metformin 3 months to treat PCOS', 'armGroupLabels': ['metformin']}, {'name': 'Acarbose', 'type': 'DRUG', 'otherNames': ['group 4'], 'description': 'Use acarbose 3 months to treat PCOS', 'armGroupLabels': ['acarbose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji Hospital Department of Endocrinology and Metabolism', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Tao Tao, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'RenJi Hospital Department of Endocrinology and Metabolism'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}