Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-01-01 @ 11:34 PM
Study NCT ID:
NCT03352869
Status:
COMPLETED
Last Update Posted:
2019-09-11
First Post:
2017-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research of Exenatide for Overweight/Obese PCOS Patients With IGR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], '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': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077270', 'term': 'Exenatide'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'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': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-09', 'studyFirstSubmitDate': '2017-11-09', 'studyFirstSubmitQcDate': '2017-11-20', 'lastUpdatePostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of intravenous blood glucose from impaired glucose regulation to normal glucose regulation', 'timeFrame': 'up to 12 weeks', 'description': 'To compare the intravenous blood glucose of three groups 12 weeks after withdrawal. All patients discontinue after 12 weeks of treatment and only routine lifestyle intervention is performed after that. All patients receive 75 g OGTT test and insulin releasing test again 12 weeks after drug withdrawal to observe the IGR remission rate. To accurately assess the insulin secretion of islet β-cell, 13 patients would be randomly selected from MET group and from EX group respectively to receive the two-step hyperglycemic clamp before the intervention and after 12-week treatment. Remission rate = Number of patients who has normal glucose tolerance 12 weeks after withdrawal / Number of patients who completed treatments × 100%'}], 'secondaryOutcomes': [{'measure': 'Improvement of hyperandrogenism', 'timeFrame': 'up to 12 weeks', 'description': 'To compare the free androgen index (FAI =total serum testosterone x 100 / Sex Hormone Binding Globulin) of three groups after 12-week treatment'}, {'measure': 'Improvement of blood lipid', 'timeFrame': 'up to 12 weeks', 'description': 'To compare the circulating lipid level(triglyceride, total cholesterol, HDL-C, LDL-C, etc.) of three groups after 12-week treatment'}, {'measure': 'Improvement of fatty liver', 'timeFrame': 'up to 12 weeks', 'description': 'To compare the number of fatty liver patients diagnosed by ultrasonography of three groups after 12-week treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polycystic Ovary Syndrome', 'Overweight and Obesity', 'Impaired Glucose Regulation', 'Exenatide', 'Metformin'], 'conditions': ['Polycystic Ovary Syndrome', 'Overweight and Obesity', 'Disorder of Glucose Regulation']}, 'referencesModule': {'references': [{'pmid': '25880805', 'type': 'BACKGROUND', 'citation': 'Kahal H, Aburima A, Ungvari T, Rigby AS, Coady AM, Vince RV, Ajjan RA, Kilpatrick ES, Naseem KM, Atkin SL. The effects of treatment with liraglutide on atherothrombotic risk in obese young women with polycystic ovary syndrome and controls. BMC Endocr Disord. 2015 Apr 2;15:14. doi: 10.1186/s12902-015-0005-6.'}, {'pmid': '18460557', 'type': 'BACKGROUND', 'citation': 'Elkind-Hirsch K, Marrioneaux O, Bhushan M, Vernor D, Bhushan R. Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2008 Jul;93(7):2670-8. doi: 10.1210/jc.2008-0115. Epub 2008 May 6.'}, {'pmid': '24256515', 'type': 'BACKGROUND', 'citation': 'Kahal H, Abouda G, Rigby AS, Coady AM, Kilpatrick ES, Atkin SL. Glucagon-like peptide-1 analogue, liraglutide, improves liver fibrosis markers in obese women with polycystic ovary syndrome and nonalcoholic fatty liver disease. Clin Endocrinol (Oxf). 2014 Oct;81(4):523-8. doi: 10.1111/cen.12369. Epub 2013 Dec 12.'}, {'pmid': '25330463', 'type': 'BACKGROUND', 'citation': 'Jensterle M, Kocjan T, Kravos NA, Pfeifer M, Janez A. Short-term intervention with liraglutide improved eating behavior in obese women with polycystic ovary syndrome. Endocr Res. 2015;40(3):133-8. doi: 10.3109/07435800.2014.966385. Epub 2014 Oct 20.'}, {'pmid': '24362411', 'type': 'BACKGROUND', 'citation': 'Jensterle Sever M, Kocjan T, Pfeifer M, Kravos NA, Janez A. Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin. Eur J Endocrinol. 2014 Feb 7;170(3):451-9. doi: 10.1530/EJE-13-0797. Print 2014 Mar.'}, {'pmid': '25726702', 'type': 'BACKGROUND', 'citation': 'Vitek W, Alur S, Hoeger KM. Off-label drug use in the treatment of polycystic ovary syndrome. Fertil Steril. 2015 Mar;103(3):605-11. doi: 10.1016/j.fertnstert.2015.01.019.'}, {'pmid': '28143456', 'type': 'RESULT', 'citation': 'Jensterle M, Kravos NA, Goricar K, Janez A. Short-term effectiveness of low dose liraglutide in combination with metformin versus high dose liraglutide alone in treatment of obese PCOS: randomized trial. BMC Endocr Disord. 2017 Jan 31;17(1):5. doi: 10.1186/s12902-017-0155-9.'}, {'pmid': '32995892', 'type': 'DERIVED', 'citation': 'Tao T, Zhang Y, Zhu YC, Fu JR, Wang YY, Cai J, Ma JY, Xu Y, Gao YN, Sun Y, Fan W, Liu W. Exenatide, Metformin, or Both for Prediabetes in PCOS: A Randomized, Open-label, Parallel-group Controlled Study. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1420-e1432. doi: 10.1210/clinem/dgaa692.'}]}, 'descriptionModule': {'briefSummary': 'Compare the therapeutic effects of exenatide, metformin and their combination for 3 months on reproductive and metabolic improvements of overweight/obese PCOS patients with impaired glucose regulation.', 'detailedDescription': 'The investigators designed a randomized control trial to compare the therapeutic effects of exenatide, metformin and their combination for 3 months on reproductive and metabolic improvements of overweight/obese PCOS patients with impaired glucose regulation. The investigators plan to enroll 183 patients. Inclusion criteria: 1) Patients who have PCOS which is diagnosed according to 2003 Rotterdam criteria; 2) Overweight / obesity diagnostic criteria is based on WHO-WPR; 3) IGR diagnostic criteria is based on 1999 WHO diagnostic criteria; 4) have been treated with dietary and behavioral intervention for 3 months but are ineffective; 5) have no use of other hypoglycemic drugs before 3 months of treatment.\n\nPatients with serious complications (cardiovascular events and recent significant liver, kidney or lung disease within 3 months); high blood pressure (\\>160/100mmHg); active infection; secondary diabetes; pregnancy; alcohol abuse; allergic to GLP-1 receptor agonist or metformin are excluded.\n\nThen the investigators plan to randomly divide the 183 patients into 3 groups: exenatide group, metformin group, and combination group, with 61 samples for each group. Each group use specific treatment (showed as the group name) for 3 months. Before and after the intervention, the blood samples would be collected to detect blood glucose, insulin, lipid profile, sex hormones, blood chemistry for liver and kidney function, hsCRP etc., as well as the anthropometric measurement and image examinations. All patients discontinue after 12 weeks of treatment and only routine lifestyle intervention is performed after that. All patients receive 75 g OGTT test and insulin releasing test again 12 weeks after drug withdrawal to observe the IGR remission rate. To accurately assess the insulin secretion of islet β-cell, 13 patients would be randomly selected from MET group and from EX group respectively to receive the two-step hyperglycemic clamp before the intervention and after 12-week treatment.\n\nThe investigators will compare the data and finally identify the treatment effect of exenatide on PCOS patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. have PCOS which is diagnosed according to 2003 Rotterdam criteria;\n2. overweight / obesity diagnostic criteria is based on WHO-WPR ;\n3. IGR diagnostic criteria is based on 1999 WHO diagnostic criteria;\n4. have been treated with dietary and behavioral intervention for 3 months but are ineffective;\n5. have no use of other hypoglycemic drugs before 3 months of treatment.\n\nExclusion Criteria:\n\n* Except for serious complications (cardiovascular events and recent significant liver, kidney or lung disease within 3 months)\n* high blood pressure (\\>160/100mmHg)\n* active infection\n* secondary diabetes\n* pregnancy\n* alcohol abuse\n* allergic to GLP-1 receptor agonist or metformin'}, 'identificationModule': {'nctId': 'NCT03352869', 'briefTitle': 'Research of Exenatide for Overweight/Obese PCOS Patients With IGR', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Research of Exenatide for Management of Reproductive and Metabolic Dysfunction in Overweight/Obese PCOS Patients With Impaired Glucose Regulation', 'orgStudyIdInfo': {'id': '[2017]077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exenatide', 'description': 'Drug: Byetta Generic name: Exenatide Dosage form: 5ug and 10ug Dosage: 10-20ug/day Frequency: twice a day Duration: 3 months', 'interventionNames': ['Drug: Exenatide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'description': 'Drug: Glucophage Generic name: Metformin Dosage form: 500mg Dosage: 1500-2000mg/day Frequency: 500mg three times a day/1000mg twice a day Duration: 3 months', 'interventionNames': ['Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Combination', 'description': 'Drug: Byetta and Glucophage Generic name: Exenatide Dosage form: Exenatide 5ug and 10ug; Metformin 500mg Dosage: Exenatide10-20ug/day; Metformin 1500-2000mg/day Frequency: Exenatide twice a day; Metformin 500mg three times a day/1000mg twice a day Duration: 3 months', 'interventionNames': ['Drug: Exenatide', 'Drug: Metformin']}], 'interventions': [{'name': 'Exenatide', 'type': 'DRUG', 'otherNames': ['Byetta'], 'description': 'Use Exenatide for 3 months to treat PCOS', 'armGroupLabels': ['Combination', 'Exenatide']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage'], 'description': 'Use Metformin for 3 months to treat PCOS', 'armGroupLabels': ['Combination', 'Metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', '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'}}}}