Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-29 @ 3:21 AM
Study NCT ID:
NCT05638893
Status:
COMPLETED
Last Update Posted:
2022-12-07
First Post:
2022-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-05', 'studyFirstSubmitDate': '2022-11-28', 'studyFirstSubmitQcDate': '2022-11-28', 'lastUpdatePostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities Arthritis Index (WOMAC)', 'timeFrame': '12 weeks', 'description': 'Measure change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) at baseline and after 12weeks of treatment.'}, {'measure': 'Weight (Kg)', 'timeFrame': '12 weeks', 'description': 'Measure change in weight in kilograms at baseline and after 12weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'Cartilage Oligomeric Matrix Protein (COMP)', 'timeFrame': '12 weeks', 'description': 'Measure change in Cartilage Oligomeric Matrix Protein (COMP) serum level at baseline and after 12weeks of treatment.'}, {'measure': 'C-terminal crosslinked telopeptide of type I collagen (CTX-1)', 'timeFrame': '12 weeks', 'description': 'Measure change in C-terminal crosslinked telopeptide of type I collagen (CTX-1) serum level at baseline and after 12weeks of treatment.'}, {'measure': 'Interleukin 1-beta (IL-1β)', 'timeFrame': '12 weeks', 'description': 'Measure change in Interleukin 1-beta (IL-1β) serum level at baseline and after 12weeks of treatment.'}, {'measure': 'Adverse drug events', 'timeFrame': '12 weeks', 'description': 'side effects'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metformin', 'knee osteoarthritis'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '38869746', 'type': 'DERIVED', 'citation': 'Aiad AAE, El-Haggar SM, El-Barbary AM, El-Afify DR. Metformin as adjuvant therapy in obese knee osteoarthritis patients. Inflammopharmacology. 2024 Aug;32(4):2349-2359. doi: 10.1007/s10787-024-01495-y. Epub 2024 Jun 13.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the possible efficacy and safety of addition of metformin to celecoxib in patients with knee osteoarthritis.', 'detailedDescription': 'Metformin is a safe, well-tolerated oral biguanide widely used as first-line therapy for type 2 diabetes for over 50 years. In addition to its glucose-lowering effects, metformin modulates inflammatory and metabolic factors resulting in weight loss and reduced inflammation and plasma lipids. Data from animal studies suggest that metformin could limit OA development and progression, possibly through activating AMPK.\n\nRetrospective cohort study of participants with OA and type 2 diabetes reported that patients receiving a combination of cyclooxygenase-2 inhibitors and metformin therapy had a lower risk of joint replacement than those receiving cyclooxygenase-2 inhibitors alone .\n\nThese findings shed light on possible therapeutic potential of metformin in treatment of OA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients have symptomatic and radiological evidence of OA in one or both knee joints.\n* Age ≥ 45 years.\n* Both obese male and female will be included (BMI ≥ 30 kg/m²).\n\nExclusion Criteria:\n\n* Patients with inflammatory rheumatic diseases, crystal deposition arthritis or infection-induced OA.\n* Patient with hypertension or diabetes mellitus.\n* Patient with hepatic or renal impairment.\n* Patients who have active peptic ulcer.\n* Patients with positive malignancy.\n* Steroid injection into the affected knee joint within 3 months of recruitment for the study.\n* Pregnant or lactating female patients.'}, 'identificationModule': {'nctId': 'NCT05638893', 'briefTitle': 'Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients', 'orgStudyIdInfo': {'id': 'Metformin knee osteoarthritis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo group', 'description': 'Placebo tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks.', 'interventionNames': ['Drug: Placebo Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Metformin group', 'description': 'Metformin 500mg tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks.', 'interventionNames': ['Drug: Metformin Hcl 500Mg Tab']}], 'interventions': [{'name': 'Placebo Tablet', 'type': 'DRUG', 'description': 'Placebo (tablet/12hr) + celecoxib (200mg/day) for three months.', 'armGroupLabels': ['Placebo group']}, {'name': 'Metformin Hcl 500Mg Tab', 'type': 'DRUG', 'otherNames': ['Cidophage 500mg Oral Tablet'], 'description': 'Metformin (500mg/12hr) + celecoxib (200mg/day) for three months.', 'armGroupLabels': ['Metformin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'country': 'Egypt', 'facility': 'Tanta university', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Sahar M El-Haggar, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Tanta University'}, {'name': 'Amal M El-Barbary, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Tanta University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'pharmacist', 'investigatorFullName': 'Amany Abd Elaal Mohamed Aiad', 'investigatorAffiliation': 'Tanta University'}}}}