Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT07130318
Status:
RECRUITING
Last Update Posted:
2025-08-19
First Post:
2025-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mediterranean Diet in Familial Mediterranean Fever: Is Fatty Liver Affected by Addition of Aerobic Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010505', 'term': 'Familial Mediterranean Fever'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-08-12', 'studyFirstSubmitQcDate': '2025-08-18', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'aspartate transaminase', 'timeFrame': 'it will be measured after 6 months', 'description': 'it is a hepatic enzyme'}], 'secondaryOutcomes': [{'measure': 'alanine transaminase', 'timeFrame': 'it will be measured after 6 months', 'description': 'it is a hepatic enzyme'}, {'measure': 'body mass index', 'timeFrame': 'it will be measured after 6 months', 'description': 'it will be measured after patient emptying his bowel and bladder'}, {'measure': 'waist circumference', 'timeFrame': 'it will be measured after 6 months', 'description': 'it will be measured at umbilical level'}, {'measure': 'high density lipoprotein', 'timeFrame': 'it will be measured after 6 months', 'description': 'it will be measured in plasma'}, {'measure': 'triglycerides', 'timeFrame': 'it will be measured after 6 months', 'description': 'it will be measured in plasma'}, {'measure': 'cholesterol', 'timeFrame': 'it will be measured after 6 months', 'description': 'it will be measured in plasma'}, {'measure': 'low density lipoprotein', 'timeFrame': 'it will be measured after 6 months', 'description': 'it will be measured in plasma'}, {'measure': 'c reactive protein', 'timeFrame': 'it will be measured after 6 months', 'description': 'it will be measured in plasma'}, {'measure': 'erythrocyte sedimentation rate', 'timeFrame': 'it will be measured after 6 months', 'description': 'it will be measured in plasma'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Familial Mediterranean Fever', 'Non-Alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'Familial Mediterranean fever (FMF) affect liver and causes some dysfunctions including non-alcoholic fatty liver.. still exercise and diet limitation is the treatment for this case', 'detailedDescription': 'Familial Mediterranean fever (FMF women with fatty liver) will be collected to be cateogarized to group I or group II. Every group OF FMF will contain 20 FMF women. Both groups will follow their colchicine (traditional daily drug therapy for FMF) in addition to Mediterranean diet for six months. Group I will also perform elliptical aerobic exercise (this exercise will be applied for 40 minutes three times weekly and this exercise will be maintained for 6 months)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': 'based on self-representation of gender identity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* familial Mediterrean fever women\n* obese women\n* women who have fatty live (non alcoholic type)\n\nExclusion Criteria:\n\n* cardiac patients\n* respiratory disease\n* renal disease\n* cancer'}, 'identificationModule': {'nctId': 'NCT07130318', 'briefTitle': 'Mediterranean Diet in Familial Mediterranean Fever: Is Fatty Liver Affected by Addition of Aerobic Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Mediterranean Diet in Familial Mediterranean Fever: Is Fatty Liver Affected by Addition of Elliptical Aerobic Exercise', 'orgStudyIdInfo': {'id': 'IRB00014233-34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group number 1', 'description': 'Familial Mediterranean fever (FMF women ) will be collected in this group. the group OF FMF will contain 20 FMF women. the group will follow their colchicine (traditional daily drug therapy for FMF) in addition to Mediterranean diet for six months. also, this group, Group I, will also perform elliptical aerobic exercise (this exercise will be applied for 40 minutes three times weekly and this exercise will be maintained for 6 months)', 'interventionNames': ['Behavioral: exercise plus diet restriction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group number 2', 'description': 'Familial Mediterranean fever (FMF women ) will be collected in this group. the group OF FMF will contain 20 FMF women. the group will follow their colchicine (traditional daily drug therapy for FMF) in addition to Mediterranean diet for six months.', 'interventionNames': ['Behavioral: diet restriction']}], 'interventions': [{'name': 'exercise plus diet restriction', 'type': 'BEHAVIORAL', 'description': 'Familial Mediterranean fever (FMF women ) will be collected in this group. the group OF FMF will contain 20 FMF women. the group will follow their colchicine (traditional daily drug therapy for FMF) in addition to Mediterranean diet for six months. also, this group, Group I, will also perform elliptical aerobic exercise (this exercise will be applied for 40 minutes three times weekly and this exercise will be maintained for 6 months)', 'armGroupLabels': ['group number 1']}, {'name': 'diet restriction', 'type': 'BEHAVIORAL', 'description': 'Familial Mediterranean fever (FMF women ) will be collected in this group. the group OF FMF will contain 20 FMF women. the group will follow their colchicine (traditional daily drug therapy for FMF) in addition to Mediterranean diet for six months.', 'armGroupLabels': ['group number 2']}]}, 'contactsLocationsModule': {'locations': [{'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': 'Ali MA Ismail, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'faculty of physical therapy Cairo university', 'geoPoint': {'lat': 30.03823, 'lon': 31.2113}}], 'centralContacts': [{'name': 'Ali MA Ismail, lecturer', 'role': 'CONTACT', 'email': 'ali.mohamed@pt.cu.edu.eg', 'phone': '01005154209'}, {'name': 'Ali Ismail, lecturer', 'role': 'CONTACT', 'email': 'allooka2012@gmail.com'}], 'overallOfficials': [{'name': 'Ali MA Ismail, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University', 'investigatorFullName': 'Ali Mohamed Ali ismail', 'investigatorAffiliation': 'Cairo University'}}}}