- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07360457
GLP1 Analogues and the Risk of Osteoarthritis
Association of GLP1 Analogues and SGLT2 Inhibitors With the Risk of Osteoarthritis in Type 2 Diabetic Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
GLP-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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Asmaa A Elsayed
- Phone Number: 01095727201
- Email: asmaa.abdelfattah@pharm.sohag.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- individuals with Type 1 Diabetes Mellitus
- non-diabetic individuals
- those taking prandial insulin
- patients with arthritis without osteoarthritis,
- those taking other medications contraindicated with study medications,
- pregnant or breastfeeding females
- those allergic to active ingredients,
- those using corticosteroids, Autoimmune disease patients or patients receiving immunotherapies, monoclonal antibody targeting TNF-α or IL-6.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
SGLT2 Group
T2DM patients receiving SGLT2 inhibitors for at least 1 year added to their standard of care
|
sodium glucose transporter-2 inhibitors
Other Names:
|
|
GLP1 Group
T2DM patients receiving GLP1 analogues for at least 1 year added to their standard of care
|
glucagon like peptide analogues
Other Names:
|
|
Control group
T2DM patients receiving only standard of care
|
Standard of care
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
WOMAC score
Time Frame: at Day 1
|
A validated, self-administered questionnaire used to assess pain, stiffness, and physical function
|
at Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS pain score
Time Frame: at Day 1
|
numerical measure to assess pain
|
at Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Asmaa Elsayed, Sohag University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLP1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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