Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-04 @ 2:12 PM
Study NCT ID:
NCT06591169
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle Changes in PCOS with OSA and NAFLD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-09', 'studyFirstSubmitDate': '2024-09-09', 'studyFirstSubmitQcDate': '2024-09-09', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'aspartate transamianse', 'timeFrame': 'it will be assessed in serum after eight weeks'}], 'secondaryOutcomes': [{'measure': 'alanine transaminase', 'timeFrame': 'it will be assessed in serum after eight weeks'}, {'measure': 'triglycerides', 'timeFrame': 'it will be assessed in serum after eight weeks'}, {'measure': 'neck circumference', 'timeFrame': 'it will be assessed after eight weeks'}, {'measure': 'waist circumference', 'timeFrame': 'it will be assessed after eight weeks'}, {'measure': 'body mass index', 'timeFrame': 'it will be assessed after eight weeks'}, {'measure': 'testesterone', 'timeFrame': 'it will be assessed in serum after eight weeks'}, {'measure': 'ratio of luteinizing hormone and follicle-stimulating hormone', 'timeFrame': 'it will be assessed after eight weeks'}, {'measure': 'apnea hyopnea index', 'timeFrame': 'it will be assessed after eight weeks'}, {'measure': 'Epworth sleeping scale', 'timeFrame': 'it will be assessed after eight weeks'}, {'measure': 'Dehydroepiandrosterone', 'timeFrame': 'it will be assessed in serum after eight weeks'}, {'measure': 'waist hip ratio', 'timeFrame': 'it will be assessed after eight weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PCOS', 'NAFLD', 'OSA']}, 'descriptionModule': {'briefSummary': 'Complain of obstructive sleeping apnea and fatty liver is common in PCOS women so lifestyle changes are recommended', 'detailedDescription': 'Forty obese PCOS men with obstructive sleeping apnea and compaint of fatty liver will participate in this trial . Group (study group) will contain twenty obese females with a complaint of PCOS and OSA and fatty liver. for eight weeks, these obese females will receive metformin tablet (thrice daily), program of low diet intake, and daily walking for 30 minutes. Group (control group) will contain twenty obese females with a complaint of PCOS and OSA and fatty liver . for eight weeks, these obese females will receive metformin tablet (thrice daily), program of low diet intake,'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': 'self-identified national gender ID', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* forty women\n* women complaint PCOS\n* women complain obstructive sleep apnea\n* women are obese\n* women complain fatty liver\n\nExclusion Criteria:\n\n* cardiac insult\n* renal insult\n* malignacy\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT06591169', 'briefTitle': 'Lifestyle Changes in PCOS with OSA and NAFLD', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Polycystic Ovarian Syndrome Women with NAFLD and Obstructive Sleeping Apnea: Program of Lifestyle Changes', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005321'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study', 'description': 'this group will contain twenty obese females with a complaint of NAFLD, PCOS and OSA. for eight weeks, these obese females will receive metformin tablet (thrice daily), program of low diet intake, and daily walking for 30 minutes', 'interventionNames': ['Behavioral: diet restriction and exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'this group will contain twenty obese females with a complaint of NAFLD, PCOS and OSA. for eight weeks, these obese females will receive metformin tablet (thrice daily) and program of low diet intake', 'interventionNames': ['Behavioral: diet restriction']}], 'interventions': [{'name': 'diet restriction and exercise', 'type': 'BEHAVIORAL', 'description': 'this group will contain twenty obese females with a complaint of NAFLD, PCOS and OSA. for eight weeks, these obese females will receive metformin tablet (thrice daily), program of low diet intake, and daily walking for 30 minutes', 'armGroupLabels': ['study']}, {'name': 'diet restriction', 'type': 'BEHAVIORAL', 'description': 'this group will contain twenty obese females with a complaint of NAFLD, PCOS and OSA. for eight weeks, these obese females will receive metformin tablet (thrice daily) and program of low diet intake', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dokki', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ali MA Ismail, lecturer', 'role': 'CONTACT', 'email': 'ali.mohamed@pt.cu.edu.eg', 'phone': '+0201005154209'}, {'name': 'Dina MA Mohamed, lecturer', 'role': 'CONTACT', 'email': 'Dina_Mahmoud@cu.edu.eg', 'phone': '+2 01068745636'}], 'facility': 'faculty of physical therapy Cairo university', 'geoPoint': {'lat': 30.03823, 'lon': 31.2113}}, {'city': 'Dokki', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ali Ismail, lecturer', 'role': 'CONTACT', 'email': 'ali.mohamed@pt.cu.edu.eg', 'phone': '+201005154209'}, {'name': 'Dina MA Mohamed, lecturer', 'role': 'CONTACT', 'email': 'Dina_Mahmoud@cu.edu.eg', 'phone': '+2 01068745636'}, {'name': 'Ali MA Ismail, Lecturer', 'role': 'CONTACT'}], 'facility': 'faculty of physical therapy Cairo university', 'geoPoint': {'lat': 30.03823, 'lon': 31.2113}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt', 'investigatorFullName': 'Ali Mohamed Ali ismail', 'investigatorAffiliation': 'Cairo University'}}}}