Knee Osteoarthritis
Conditions
Keywords
Metformin, knee osteoarthritis
Brief summary
This study aims to evaluate the possible efficacy and safety of addition of metformin to celecoxib in patients with knee osteoarthritis.
Detailed description
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.
Interventions
DRUGPlacebo Tablet
Placebo (tablet/12hr) + celecoxib (200mg/day) for three months.
DRUGMetformin Hcl 500Mg Tab
Metformin (500mg/12hr) + celecoxib (200mg/day) for three months.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients have symptomatic and radiological evidence of OA in one or both knee joints. * Age ≥ 45 years. * Both obese male and female will be included (BMI ≥ 30 kg/m²).
Exclusion criteria
* Patients with inflammatory rheumatic diseases, crystal deposition arthritis or infection-induced OA. * Patient with hypertension or diabetes mellitus. * Patient with hepatic or renal impairment. * Patients who have active peptic ulcer. * Patients with positive malignancy. * Steroid injection into the affected knee joint within 3 months of recruitment for the study. * Pregnant or lactating female patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 12 weeks | Measure change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) at baseline and after 12weeks of treatment. |
| Weight (Kg) | 12 weeks | Measure change in weight in kilograms at baseline and after 12weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cartilage Oligomeric Matrix Protein (COMP) | 12 weeks | Measure change in Cartilage Oligomeric Matrix Protein (COMP) serum level at baseline and after 12weeks of treatment. |
| C-terminal crosslinked telopeptide of type I collagen (CTX-1) | 12 weeks | Measure change in C-terminal crosslinked telopeptide of type I collagen (CTX-1) serum level at baseline and after 12weeks of treatment. |
| Interleukin 1-beta (IL-1β) | 12 weeks | Measure change in Interleukin 1-beta (IL-1β) serum level at baseline and after 12weeks of treatment. |
| Adverse drug events | 12 weeks | side effects |
Countries
Egypt
Outcome results
None listed