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OpenTrials
Completed

NCT Number: NCT05638893

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Tanta university

Tanta, Gharbia Governorate, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo Tablet

Drug

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

Metformin Hcl 500Mg Tab

Drug

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

Other names: Cidophage 500mg Oral Tablet

Primary outcomes

  1. Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Time frame: 12 weeks

    Measure change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) at baseline and after 12weeks of treatment.

  2. Weight (Kg)

    Time frame: 12 weeks

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

Secondary outcomes

  1. Cartilage Oligomeric Matrix Protein (COMP)

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

    Measure change in C-terminal crosslinked telopeptide of type I collagen (CTX-1) serum level at baseline and after 12weeks of treatment.

  3. Interleukin 1-beta (IL-1β)

    Time frame: 12 weeks

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

  4. Adverse drug events

    Time frame: 12 weeks

    side effects

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 6, 2022
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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