Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Metformin on Patients With Osteoarthritis

NCT05034029

Osteoarthritis

UNKNOWN NA

The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.

NCT05332795

Gouty Arthritis

COMPLETED NA

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

NCT04767841

Osteo Arthritis Knee

WITHDRAWN PHASE1/PHASE2

Metformin in Safety and Efficacy in Gouty Patients

NCT06924658

Gout

RECRUITING PHASE2

The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients

NCT04068246

Rheumatoid Arthritis

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo group

Placebo tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks.

Group Type EXPERIMENTAL

Placebo Tablet

Intervention Type DRUG

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

Metformin group

Metformin 500mg tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks.

Group Type EXPERIMENTAL

Metformin Hcl 500Mg Tab

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo Tablet

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

Intervention Type DRUG

Metformin Hcl 500Mg Tab

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cidophage 500mg Oral Tablet

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No