Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients

Tanta University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

Placebo TabletDRUG

Placebo (tablet/12hr) + celecoxib (200mg/day) for three months.

Metformin Hcl 500Mg TabDRUG

Metformin (500mg/12hr) + celecoxib (200mg/day) for three months.

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tanta university

Tanta, Gharbia Governorate, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Weight (Kg)

Measure change in weight in kilograms at baseline and after 12weeks of treatment.

Time frame: 12 weeks

Secondary Outcomes

Cartilage Oligomeric Matrix Protein (COMP)

Measure change in Cartilage Oligomeric Matrix Protein (COMP) serum level at baseline and after 12weeks of treatment.

Time frame: 12 weeks

C-terminal crosslinked telopeptide of type I collagen (CTX-1)

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

Interleukin 1-beta (IL-1β)

Measure change in Interleukin 1-beta (IL-1β) serum level at baseline and after 12weeks of treatment.

Time frame: 12 weeks

Adverse drug events

side effects

Time frame: 12 weeks

Data from ClinicalTrials.gov

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