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This study aims to evaluate the possible efficacy and safety of addition of metformin to celecoxib in patients with knee osteoarthritis.
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.
Retrospective 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 .
These findings shed light on possible therapeutic potential of metformin in treatment of OA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Experimental | Placebo tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks. |
|
| Metformin group | Experimental | Metformin 500mg tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Tablet | Drug | Placebo (tablet/12hr) + celecoxib (200mg/day) for three months. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Measure change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) at baseline and after 12weeks of treatment. | 12 weeks |
| Weight (Kg) | Measure change in weight in kilograms at baseline and after 12weeks of treatment. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cartilage Oligomeric Matrix Protein (COMP) | Measure change in Cartilage Oligomeric Matrix Protein (COMP) serum level at baseline and after 12weeks of treatment. | 12 weeks |
| C-terminal crosslinked telopeptide of type I collagen (CTX-1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sahar M El-Haggar, Professor | Tanta University | Study Chair |
| Amal M El-Barbary, Professor | Tanta University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta university | Tanta | Gharbia Governorate | 31527 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38869746 | Derived | 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. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004304 |
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| Metformin Hcl 500Mg Tab |
| Drug |
Metformin (500mg/12hr) + celecoxib (200mg/day) for three months. |
|
|
Measure change in C-terminal crosslinked telopeptide of type I collagen (CTX-1) serum level at baseline and after 12weeks of treatment.
| 12 weeks |
| Interleukin 1-beta (IL-1β) | Measure change in Interleukin 1-beta (IL-1β) serum level at baseline and after 12weeks of treatment. | 12 weeks |
| Adverse drug events | side effects | 12 weeks |
| D012216 |
| Rheumatic Diseases |
| Dosage Forms |
| D004364 | Pharmaceutical Preparations |