Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients

Phase 2

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Placebo Tablet; Drug: Metformin Hcl 500Mg Tab

• Registration Number: NCT05638893
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2022-03-12
• Study Completion: 2022-04-15
• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-11-28
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Study First Posted: 2022-12-06
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo Tablet	Placebo tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks.
Metformin group	Metformin Hcl 500Mg Tab	Metformin 500mg tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tanta university; 🇪🇬 Tanta, Gharbia, Egypt