NCT04767841

The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Patients With Knee Osteoarthritis

The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Patients With Knee Osteoarthritis: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sadat City University · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

metformin alleviates drug-induced osteoarthritis (OA)-like change in mice knee joint through activating autophagy and downregulating apoptosis. Metformin exerts its protective effects against OA through the AMPKa2/ SIRT1 pathway. Metformin suppresses IL-1β-induced oxidative and osteoarthritis-like inflammatory changes by enhancing the SIRT3/PINK1/Parkin signaling pathway, thereby indicating metformin's potential in prevention and treatment of osteoarthritic joint disease.

Conditions

• Osteo Arthritis Knee

Interventions

Type	Name	Description
DRUG	Metformin	Metformin 1000mg tablet plus celecoxib 200 mg capsule
DRUG	Placebo	Placebo tablet plus celecoxib 200 mg capsule

Timeline

• Start date: 2021-02-16
• Primary completion: 2024-06-30
• Completion: 2024-12-31
• First posted: 2021-02-23
• Last updated: 2025-07-14

Locations

1 site across 1 country: Egypt