Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients

This study aims to evaluate the possible efficacy and safety of addition of metformin to celecoxib in patients with knee osteoarthritis.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: Placebo Tablet; Drug: Metformin Hcl 500Mg Tab

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo group; Placebo tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks.	Drug: Placebo Tablet; Placebo (tablet/12hr) + celecoxib (200mg/day) for three months.
Experimental: Metformin group; Metformin 500mg tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks.	Drug: Metformin Hcl 500Mg Tab; Metformin (500mg/12hr) + celecoxib (200mg/day) for three months.; Other Names: Cidophage 500mg Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Study Chair: Sahar M El-Haggar, Professor, Tanta University; Study Chair: Amal M El-Barbary, Professor, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): March 12, 2022
• Study Completion (Actual): April 15, 2022

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: knee osteoarthritis; Metformin
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: Metformin knee osteoarthritis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No