Ignite Creation Date:
2025-12-24 @ 6:57 PM
Ignite Modification Date:
2025-12-29 @ 7:25 AM
Study NCT ID:
NCT05125757
Status:
UNKNOWN
Last Update Posted:
2021-11-18
First Post:
2021-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle Modification in Psoriatic Patients With Fatty Liver
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-07', 'studyFirstSubmitDate': '2021-10-17', 'studyFirstSubmitQcDate': '2021-11-07', 'lastUpdatePostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psoriasis Area and Severity Index', 'timeFrame': 'It will be measured after 12 weeks', 'description': 'it is an index used to measure level and severity of psoriasis'}], 'secondaryOutcomes': [{'measure': 'Dermatology Life Quality Index', 'timeFrame': 'It will be measured after 12 weeks', 'description': 'it is a questinnaire used to assess life quality in psoriasis humans'}, {'measure': 'triglycerides', 'timeFrame': 'It will be measured after 12 weeks', 'description': 'will measured in plasma'}, {'measure': 'AST', 'timeFrame': 'It will be measured after 12 weeks', 'description': 'it is plasma aspartate transaminase'}, {'measure': 'ALT', 'timeFrame': 'It will be measured after 12 weeks', 'description': 'it is plasma Alanine transaminase'}, {'measure': 'BMI', 'timeFrame': 'It will be measured after 12 weeks', 'description': 'it is body mass index'}, {'measure': 'waist circumference', 'timeFrame': 'It will be measured after 12 weeks', 'description': 'it will be measured at the level of umbilicus'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis', 'Fatty Liver']}, 'descriptionModule': {'briefSummary': 'Several recent reports have shown an increased prevalence of nonalcoholic fatty liver disease (NAFLD) in those with psoriasis, which may reflect the increased occurrence of metabolic syndrome in this patient population.', 'detailedDescription': 'the recruitment of 60 fatty live men with chronic disease, psoriasis, will be classified to lifestyle modification group (foe 12 weeks, this patients will take supervised energy or diet restriction program plus their usual immunosuppressive drugs ) and control group will continue their drug program only)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'self-representation of gender identity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* psoriasis obese patients with coexisting fatty liver\n* chronic plaque psoriasis\n* patients who will not show any change in immuno-modulating psoriasis therapies for at least five months before participation in the study.\n\nExclusion Criteria:\n\n* no metabolic syndrome\n* no renal or cardiac or pulmonary disorders\n* other types of psoriasis'}, 'identificationModule': {'nctId': 'NCT05125757', 'briefTitle': 'Lifestyle Modification in Psoriatic Patients With Fatty Liver', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Response of Fatty Liver to Lifestyle Modification in Psoriasis Patients', 'orgStudyIdInfo': {'id': 'P.T.REC/012/003344'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'The patients of this group will receive their usual immuno-modulating therapy plus life style modification (energy or diet restriction in addition to daily walking, 15000 steps)', 'interventionNames': ['Other: lifestyle modification']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'The participants of this group will receive their usual immuno-modulating therapy and continuing their usual diet and activities', 'interventionNames': ['Other: usual lifestyle']}], 'interventions': [{'name': 'lifestyle modification', 'type': 'OTHER', 'description': 'for 12 week, the patients of this group will receive their usual immuno-modulating therapy plus life style modification (energy or diet restriction in addition to daily walking, 15000 steps)', 'armGroupLabels': ['intervention group']}, {'name': 'usual lifestyle', 'type': 'OTHER', 'description': 'the patients will receive the usual immuno-modulating therapy with continued usual diet and activities', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'state': 'Dokki', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ali Ismail, lecturer', 'role': 'CONTACT', 'email': 'allooka2012@gmail.com', 'phone': '02 01005154209'}], 'facility': 'Faculty of Physical Therapy Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Ali Ismail, lecturer', 'role': 'CONTACT', 'email': 'allooka2012@gmail.com', 'phone': '02 01005154209'}], 'overallOfficials': [{'name': 'Ali 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'}}}}