Tanta university
Tanta, Gharbia Governorate, 31527, Egypt
NCT Number: NCT05638893
This study aims to evaluate the possible efficacy and safety of addition of metformin to celecoxib in patients with knee osteoarthritis.
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Notify Me45 year and older
All sexes
Interventional
Phase 2 / Phase 3
Tanta, Gharbia Governorate, 31527, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placebo (tablet/12hr) + celecoxib (200mg/day) for three months.
Metformin (500mg/12hr) + celecoxib (200mg/day) for three months.
Other names: Cidophage 500mg Oral Tablet
Time frame: 12 weeks
Measure change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) at baseline and after 12weeks of treatment.
Time frame: 12 weeks
Measure change in weight in kilograms at baseline and after 12weeks of treatment.
Time frame: 12 weeks
Measure change in Cartilage Oligomeric Matrix Protein (COMP) serum level at baseline and after 12weeks of treatment.
Time frame: 12 weeks
Measure change in C-terminal crosslinked telopeptide of type I collagen (CTX-1) serum level at baseline and after 12weeks of treatment.
Time frame: 12 weeks
Measure change in Interleukin 1-beta (IL-1β) serum level at baseline and after 12weeks of treatment.
Time frame: 12 weeks
side effects
Tanta University
Other
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