Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-03-04 @ 11:11 PM
Study NCT ID:
NCT05332795
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2022-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015210', 'term': 'Arthritis, Gouty'}], 'ancestors': [{'id': 'D006073', 'term': 'Gout'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic 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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-25', 'studyFirstSubmitDate': '2022-04-02', 'studyFirstSubmitQcDate': '2022-04-15', 'lastUpdatePostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health-related quality of life HRQOL', 'timeFrame': 'at 3 months post intervention.', 'description': 'Health-related quality of life HRQOL was assessed using the SF-36 subscale of physical functioning (PF-10), as Lower PF-10 scores (range 0-100) imply more functional limitations, and vice versa.'}], 'primaryOutcomes': [{'measure': 'Serological remission criteria', 'timeFrame': 'at 3 months post intervention.', 'description': 'by measuring serum uric acid for patients of the present study, it must be less than 6 mg/dL.'}, {'measure': 'Articular remission criteria', 'timeFrame': 'at 3 months post intervention.', 'description': 'by examining the number of swollen and tender joints score, they must be less than 2 tender and swollen joints..'}, {'measure': 'Clinical remission criteria', 'timeFrame': 'at 3 months post intervention.', 'description': 'by assessing the grade of joint pain, it must be reduced from the first visit(regarding Visual analogue scale'}], 'secondaryOutcomes': [{'measure': 'Gout Impact Scale (GIS)', 'timeFrame': 'at 3 months post intervention.', 'description': 'by measuring GIS score, as higher scores in the GIS (range 0-100) imply a greater restriction of activity and a greater impact of gout and vice versa.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gouty Arthritis']}, 'descriptionModule': {'briefSummary': 'Objective:\n\nTo study the impact of metformin on the outcome of gouty arthritis in a cohort of Egyptian gouty patients, and to evaluate its effect on local joint inflammation, inflammatory cytokines (IL-1β and IL-6), and life quality.\n\nMethods:\n\nA prospective randomized, single-blinded parallel randomized control study included 100 patients with active inflammatory gouty arthritis were randomized to receive metformin (1000mg/day) or placebo in addition to the traditional lines of treatment of gout. The clinical and laboratory data of the patients will be analyze at baseline, then after 3, and 6 months, with the assessment of gout disease activity, in addition, serum IL-1β and IL-6, the number of attacks per year, treatment satisfaction, quality of life, and disability index were evaluated at the 6th month from starting metformin and placebo therapy.', 'detailedDescription': 'Background: Metformin has anti-inflammatory properties, as it suppresses the inflammatory process by down-regulating the transcription factor, nuclear factor kappa B (NF-kB), through AMP-activated protein kinase (AMPK)-dependent and independent pathways.\n\nObjective:\n\nTo study the impact of metformin on the outcome of gouty arthritis in a cohort of Egyptian gouty patients, and to evaluate its effect on local joint inflammation, inflammatory cytokines (IL-1β and IL-6), and life quality.\n\nMethods:\n\nA prospective randomized, single-blinded parallel randomized control study included 100 patients with active inflammatory gouty arthritis were randomized to receive metformin (1000mg/day) or placebo in addition to the traditional lines of treatment of gout. The clinical and laboratory data of the patients will be analyzed at baseline, then after 3, and 6 months, with the assessment of gout disease activity, in addition, serum IL-1β and IL-6, the number of attacks per year, treatment satisfaction, quality of life, and disability index were evaluated at the 6th month from starting metformin and placebo therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gouty patients who fulfilled the American College of Rheumatology clinical criteria.\n* gouty patients with active inflammatory arthritis.\n\nExclusion Criteria:\n\n* Patients with any type of inflammatory arthritis.\n* Patients with systemic disease as diabetes, hypertension,\n* Patients with hyperlipidemia, coronary artery disease,\n* Patients with renal or hepatic insults,\n* pregnant and lactating females'}, 'identificationModule': {'nctId': 'NCT05332795', 'acronym': 'Mets in gout', 'briefTitle': 'The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.', 'orgStudyIdInfo': {'id': '1478'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group 1: gouty patients on metformin.', 'description': 'metformin users: include gouty patients, who will receive metformin tablets (1000 mg) once daily for about 3 months.', 'interventionNames': ['Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'gouty patients on placebo.', 'description': 'placebo users: include gouty patients, who were on placebo tablets once daily for about 3 months.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'gouty patients, will receive metformin tablets (1000 mg) once daily for about 3 months.', 'armGroupLabels': ['group 1: gouty patients on metformin.']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'gouty patients, will receive placebo tablets once daily for about 3 months.', 'armGroupLabels': ['gouty patients on placebo.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '123455', 'city': 'Menoufia Governorate', 'state': 'MD', 'country': 'Egypt', 'facility': 'Dalia Salah Saif'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of physical medicine,rheumatology and rehabilitation.', 'investigatorFullName': 'Dalia Salah Saif', 'investigatorAffiliation': 'Menoufia University'}}}}