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Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients

T

Tanta University

Status and phase

Completed
Phase 3
Phase 2

Conditions

Knee Osteoarthritis

Treatments

Drug: Metformin Hcl 500Mg Tab
Drug: Placebo Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT05638893
Metformin knee osteoarthritis

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

Placebo group
Experimental group
Description:
Placebo tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks.
Treatment:
Drug: Placebo Tablet
Metformin group
Experimental group
Description:
Metformin 500mg tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks.
Treatment:
Drug: Metformin Hcl 500Mg Tab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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