Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients

Knee Osteoarthritis Clinical Trial

Official title:

Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05638893
• Other study ID #: Metformin knee osteoarthritis
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 1, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: December 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 15, 2022
• Est. primary completion date: March 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Placebo Tablet
Placebo (tablet/12hr) + celecoxib (200mg/day) for three months.
• Metformin Hcl 500Mg Tab
Metformin (500mg/12hr) + celecoxib (200mg/day) for three months.

Locations

Country	Name	City	State
Egypt	Tanta university	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Weight (Kg)	Measure change in weight in kilograms at baseline and after 12weeks of treatment.	12 weeks
Secondary	Cartilage Oligomeric Matrix Protein (COMP)	Measure change in Cartilage Oligomeric Matrix Protein (COMP) serum level at baseline and after 12weeks of treatment.	12 weeks
Secondary	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
Secondary	Interleukin 1-beta (IL-1ß)	Measure change in Interleukin 1-beta (IL-1ß) serum level at baseline and after 12weeks of treatment.	12 weeks
Secondary	Adverse drug events	side effects	12 weeks