Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:17 AM
Study NCT ID:
NCT07360457
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-22
First Post:
2026-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GLP1 Analogues and the Risk of Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 390}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-16', 'studyFirstSubmitDate': '2026-01-08', 'studyFirstSubmitQcDate': '2026-01-16', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WOMAC score', 'timeFrame': 'at Day 1', 'description': 'A validated, self-administered questionnaire used to assess pain, stiffness, and physical function'}], 'secondaryOutcomes': [{'measure': 'VAS pain score', 'timeFrame': 'at Day 1', 'description': 'numerical measure to assess pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GLP-1'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Assessing the effects of GLP1 RA Vs SGLT2 Inhibitors vs. Standard of care in joint pain, physical function, stiffness, and improving Quality of Life for patients with type 2 diabetes.', 'detailedDescription': 'Osteoarthritis (OA) is a multifactorial joint disease related to multiple inflammatory pathways which are triggered by mechanical and cellular stress, leading to increased production of pro-inflammatory mediators, reactive oxygen species, advanced glycation end products (AGEs). These mediators promote the release of proteolytic enzymes, which degrade the cartilage matrix. A recent study emphasized on the relation between metabolic syndrome and OA, considering metabolic dysregulation as a major factor in OA progression.\n\nGLP-1 receptor agonists lower blood sugar by boosting glucose-dependent insulin release, reducing glucagon secretion, and slowing stomach emptying. GLP-1RA is present in both healthy and osteoarthritic cartilage, indicating a direct effect on chondrocytes. so it can decrease the accumulation of AGEs, which is the main cause of OA. It also reduces appetite, leading to weight loss which decreases the mechanical stress on joints. GLP downregulates proinflammatory cytokines (IL-6, TNF-a). also inhibits NF-κB pathway. which has a role in promoting osteoclast formation, so GLP plays a protective role in OA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '130 T2DM patients will be admitted in each group Group 1 : T2DM patients receiving SGLT2 inhibitors for at least 1 year added to their standard of care Group 2: T2DM patients receiving GLP1 analogues for at least 1 year added to their standard of care Group 3: T2DM patients receiving only standard of care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged above 50 years old with a previous diagnosis of T2DM according to ADA 2025, who have been on either SGLT2 inhibitors or GLP-1 analogs for at least one year.\n\nExclusion Criteria:\n\n* individuals with Type 1 Diabetes Mellitus\n* non-diabetic individuals\n* those taking prandial insulin\n* patients with arthritis without osteoarthritis,\n* those taking other medications contraindicated with study medications,\n* pregnant or breastfeeding females\n* those allergic to active ingredients,\n* those using corticosteroids, Autoimmune disease patients or patients receiving immunotherapies, monoclonal antibody targeting TNF-α or IL-6.'}, 'identificationModule': {'nctId': 'NCT07360457', 'briefTitle': 'GLP1 Analogues and the Risk of Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Association of GLP1 Analogues and SGLT2 Inhibitors With the Risk of Osteoarthritis in Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': 'GLP1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SGLT2 Group', 'description': 'T2DM patients receiving SGLT2 inhibitors for at least 1 year added to their standard of care', 'interventionNames': ['Drug: SGLT2 inhibitor']}, {'label': 'GLP1 Group', 'description': 'T2DM patients receiving GLP1 analogues for at least 1 year added to their standard of care', 'interventionNames': ['Drug: GLP-1 analog']}, {'label': 'Control group', 'description': 'T2DM patients receiving only standard of care', 'interventionNames': ['Drug: Antidiabetic']}], 'interventions': [{'name': 'GLP-1 analog', 'type': 'DRUG', 'otherNames': ['GLP1 receptor agonist'], 'description': 'glucagon like peptide analogues', 'armGroupLabels': ['GLP1 Group']}, {'name': 'SGLT2 inhibitor', 'type': 'DRUG', 'otherNames': ['gliflozin'], 'description': 'sodium glucose transporter-2 inhibitors', 'armGroupLabels': ['SGLT2 Group']}, {'name': 'Antidiabetic', 'type': 'DRUG', 'otherNames': ['Control'], 'description': 'Standard of care', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Asmaa A Elsayed', 'role': 'CONTACT', 'email': 'asmaa.abdelfattah@pharm.sohag.edu.eg', 'phone': '01095727201'}], 'overallOfficials': [{'name': 'Asmaa Elsayed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of clinical pharmacy', 'investigatorFullName': 'Asmaa Abdelfattah Elsayed', 'investigatorAffiliation': 'Beni-Suef University'}}}}