Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT04969627
Status:
COMPLETED
Last Update Posted:
2022-04-14
First Post:
2021-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.
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'}, {'id': 'D000077270', 'term': 'Exenatide'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-07-17', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body weight', 'timeFrame': '12 weeks', 'description': 'Change in body weight'}], 'secondaryOutcomes': [{'measure': 'Change in body mass index (BMI)', 'timeFrame': '12 weeks', 'description': 'Change in body mass index (BMI)'}, {'measure': 'Change in waist circumference(WC)', 'timeFrame': '12 weeks', 'description': 'Change in waist circumference(WC)'}, {'measure': 'Change in Ferriman-Gallwey score', 'timeFrame': '12 weeks', 'description': 'Change in Ferriman-Gallwey score，the range of Ferriman-Gallwey score is 0-9, higher scores mean a worse outcome.'}, {'measure': 'Change in Acne severity score', 'timeFrame': '12 weeks', 'description': 'Change in Acne severity score,the range of acne severity score is 0-9, higher scores mean a worse outcome.'}, {'measure': 'Changes in frequency of menstrual cycle', 'timeFrame': '12 weeks', 'description': 'Changes in frequency of menstrual cycle'}, {'measure': 'Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)', 'timeFrame': '12 weeks', 'description': 'glucose obtained at 0,30,60 and 120 minutes during the OGTT.'}, {'measure': 'Changes in Luteinizing Hormone (LH)', 'timeFrame': '12 weeks', 'description': 'Changes in Luteinizing Hormone (LH)'}, {'measure': 'Changes in follicle stimulating hormone (FSH)', 'timeFrame': '12 weeks', 'description': 'Changes in follicle stimulating hormone (FSH)'}, {'measure': 'Changes in LH/FSH', 'timeFrame': '12 weeks', 'description': 'Changes in LH/FSH'}, {'measure': 'Changes in prolactin (PRL)', 'timeFrame': '12 weeks', 'description': 'Changes in prolactin (PRL)'}, {'measure': 'Changes in progesterone (Prog)', 'timeFrame': '12 weeks', 'description': 'Changes in progesterone (Prog)'}, {'measure': 'Changes in total testosterone (TT)', 'timeFrame': '12 weeks', 'description': 'Changes in total testosterone (TT)'}, {'measure': 'Changes in free testosterone (FT)', 'timeFrame': '12 weeks', 'description': 'Changes in free testosterone (FT)'}, {'measure': 'Changes in free androgen index (FAI)', 'timeFrame': '12 weeks', 'description': 'Changes in free androgen index (FAI)'}, {'measure': 'Changes in sex hormone binding globulin (SHBG)', 'timeFrame': '12 weeks', 'description': 'Changes in sex hormone binding globulin (SHBG)'}, {'measure': 'Changes in dehydroepiandrosterone sulfate (DHEAS)', 'timeFrame': '12 weeks', 'description': 'Changes in dehydroepiandrosterone sulfate (DHEAS)'}, {'measure': 'Changes in anti-müllerian hormone (AMH)', 'timeFrame': '12 weeks', 'description': 'Changes in anti-müllerian hormone (AMH)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'To study the effects of GLP-1 analogues combined with metformin and metformin on gonadal and metabolic profiles in PCOS patients with BMI ≥ 24 in China. 60 cases of overweight PCOS patients were collected from Shengjing hospital. The intervention period was 3 months after intervention with met or met + GLP-1. To evaluate the improvement of met or met + GLP-1 in the treatment of hyperandremia, glucose metabolism, BMI, waist circumference, menstruation, hairiness and acne in PCOS patients with different BMI.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Females 18 years to 40 years of age Diagnosed as PCOS by the 2003 Rotterdam criteria\n2. Overweight/obesity (BMI≥24 kg/m2)\n3. No pregnant plan in recent 6 months\n4. Written consent for participation in the study\n\nExclusion Criteria:\n\n1. type 1 or type 2 diabetes mellitus\n2. Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia\n3. Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)\n4. Serious systemic disease or malignant tumor\n5. History of pancreatitis (chronic, acute or recurrent)\n6. Body weight change ≥10% at 3 months before treatment\n7. Used oral contraceptives or sex hormone drugs in the past 1 month\n8. Used oral glucocorticoids in the past 1 month\n9. Substance (alcohol or drug) abuse or dependence within 3 months\n10. Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (\\>10g/d)\n11. Subjects have a severe systemic disease, such as cardiovascular system, Renal impairment (eGFR\\<60ml/min/1.73m2)\n12. Increase of transaminases up to \\< 2.5 times of upper limit of normal value\n13. Have a history of thromboembolic disease or thrombotic tendency\n14. Subjects in pregnant or lactating or within 1 year after delivery\n15. Subjects have an allergic history to the drugs used in the study\n16. Subjects have participated in other clinical researches of medicine within 1 month prior to randomization\n17. Use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or OTC) within 30 days before screening"}, 'identificationModule': {'nctId': 'NCT04969627', 'briefTitle': 'Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.', 'organization': {'class': 'OTHER', 'fullName': 'Shengjing Hospital'}, 'officialTitle': 'Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.', 'orgStudyIdInfo': {'id': '2020PS624K'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin (BMI<24)', 'description': 'Subjects: PCOS patients whoseBMI\\<24 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': 'Metformin (BMI≥24)', 'description': 'Subjects: PCOS patients whoseBMI≥24 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 (BMI<24)', 'description': 'Subjects: PCOS patients whoseBMI\\<24 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: Metformin', 'Drug: Exenatide']}, {'type': 'EXPERIMENTAL', 'label': 'Combination (BMI≥24)', 'description': 'Subjects: PCOS patients whoseBMI≥24 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: Metformin', 'Drug: Exenatide']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'Use Metformin for 3 months to treat PCOS', 'armGroupLabels': ['Combination (BMI<24)', 'Combination (BMI≥24)', 'Metformin (BMI<24)', 'Metformin (BMI≥24)']}, {'name': 'Exenatide', 'type': 'DRUG', 'description': 'Use Exenatide for 3 months to treat PCOS', 'armGroupLabels': ['Combination (BMI<24)', 'Combination (BMI≥24)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110004', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bing He', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bing He', 'investigatorAffiliation': 'Shengjing Hospital'}}}}