Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
Study NCT ID:
NCT05386706
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2022-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treating PCOS With Digital Intervention vs. Metformin
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2022-05-18', 'studyFirstSubmitQcDate': '2022-05-18', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Homeostasis model assessment of insulin resistance', 'timeFrame': '3 months', 'description': 'insulin resistance index'}], 'secondaryOutcomes': [{'measure': 'Anthropometry', 'timeFrame': '3 months', 'description': 'body mass index (kg/m2)'}, {'measure': 'menstrual frequency', 'timeFrame': '3 months', 'description': 'number of menstruation in a year'}, {'measure': 'fasting glucose', 'timeFrame': '3 months', 'description': 'fasting glucose（mmol/L)'}, {'measure': 'fasting insulin', 'timeFrame': '3 months', 'description': 'fasting insulin（mmol/L)'}, {'measure': 'Total cholesterol', 'timeFrame': '3 months', 'description': 'Total cholesterol (mmol/L)'}, {'measure': 'Triglycerides', 'timeFrame': '3 months', 'description': 'Triglycerides (mmol/L)'}, {'measure': 'HDL-c', 'timeFrame': '3 months', 'description': 'HDL-c (mmol/L)'}, {'measure': 'LDL-c', 'timeFrame': '3 months', 'description': 'LDL-c (mmol/L)'}, {'measure': 'total testosterone', 'timeFrame': '3 months', 'description': 'total testosterone (nmol/L)'}, {'measure': 'free testosterone', 'timeFrame': '3 months', 'description': 'free testosterone (nmol/L)'}, {'measure': 'Sex hormone-binding globulin', 'timeFrame': '3 months', 'description': 'Sex hormone-binding globulin (nmol/L)'}, {'measure': 'Androstenedione', 'timeFrame': '3 months', 'description': 'Androstenedione (ng/ml)'}, {'measure': 'Dehydroepiandrosterone', 'timeFrame': '3 months', 'description': 'Dehydroepiandrosterone (ug/dl)'}, {'measure': 'International Physical Activity Questionnaire (IPAQ)', 'timeFrame': '3 months', 'description': 'Assess physical activity situation in women with PCOS.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '3 months', 'description': 'Assess sleep situation in women with PCOS.'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '3 months', 'description': 'To evaluate anxiety and depression in PCOS women.'}, {'measure': 'Three-Factor Eating Questionnaire (TFEQ-R21)', 'timeFrame': '3 months', 'description': 'Assess eating behavior in women with PCOS.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome']}, 'referencesModule': {'references': [{'pmid': '39357046', 'type': 'DERIVED', 'citation': 'Dilimulati D, Shao X, Wang L, Cai M, Zhang Y, Lu J, Wang Y, Liu H, Kuang M, Chen H, Zhang M, Qu S. Efficacy of WeChat-Based Digital Intervention Versus Metformin in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial. J Med Internet Res. 2024 Oct 2;26:e55883. doi: 10.2196/55883.'}]}, 'descriptionModule': {'briefSummary': "With the change in environment and lifestyle, and the improvement of people's understanding of PCOS, the incidence of PCOS is increasing worldwide. According to statistics, the prevalence of PCOS in premenopausal women is as high as 5-20%. Lifestyle interventions are the main treatment option for patients with PCOS. In addition, research has shown that digital therapy can effectively improve behavior changes in diet, exercise, and medication adherence, predict disease progression, reduce the frequency of disease-related symptoms, and promote effective disease management. This study aimed to investigate the efficacy of digital intervention versus traditional metformin monotherapy in patients with PCOS.", 'detailedDescription': 'This study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFemale aged 18- 45; Meet Rotterdam criteria; Insulin Resistance\n\nExclusion Criteria:\n\nWomen who are pregnant or have a pregnancy plan within six months; Congenital adrenocortical hyperplasia; Hyperprolactinemia; Hyperthyroidism or hypothyroidism; Abnormal liver function (≥ 3 times the upper limit of the normal range); Abnormal renal function (GFR\\<60ml/min/1.73m2); Adrenal or ovarian tumors secreting androgens; Used contraceptives, metformin, pioglitazone, and antidepressant medication in the last 3 months.'}, 'identificationModule': {'nctId': 'NCT05386706', 'briefTitle': 'Treating PCOS With Digital Intervention vs. Metformin', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Treating Polycystic Ovarian Syndrome (PCOS) With Digital Intervention vs. Metformin', 'orgStudyIdInfo': {'id': 'Digital Intervention PCOS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Intervention', 'description': 'A mini program-based digital intervention.', 'interventionNames': ['Behavioral: Digital Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'description': 'Traditional metformin monotherapy.', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Digital Intervention', 'type': 'BEHAVIORAL', 'description': 'This study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.', 'armGroupLabels': ['Digital Intervention']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Metformin treatment'], 'description': 'Traditional metformin monotherapy.', 'armGroupLabels': ['Metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200070', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Department of Endocrinology, Shanghai Tenth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Shen Qu, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': "Shanghai 10th People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Zhang Manna', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}