Evaluation of the effectiveness of metformin in WOMAC index of overweight knee osteoarthritis patients

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 88

Inclusion Criteria

Patients who, based on the radiography and ACR criteria, have knee osteoarthritis grades 2 & 3 according to the Kellgren and Lawrence criteria (Kellgren and Lawrence grade 2, the presence of osteophytes and joint space narrowing & grade 3 confirming the presence of more numbers of sclerosis and osteophyte).
50 to 75 years olds Man or woman
BMI body mass index (=24 kg/m2)
VAS Knee pain score= 2 on 10
Primary Osteoarthritis (not secondary OA due to trauma or inflammatory arthritis)
The person is willing and able to follow the study instructions and go to the clinic for a visit
No history of performing knee arthroscopy and injecting corticosteroids in the knee within less than 6 months from the beginning of the study
No allergy to any of the compounds used in the study
No history of severe trauma in the knee area
No history of other rheumatic diseases such as rheumatoid arthritis, psoriatic arthritis and others
No active malignancy, cancer or other life-destructive diseases and Type 1 or type 2 diabetes mellitus, hypoxic conditions (corpulmonary-congestive heart failure-acute MI-peripheral artery disease), uncontrolled high blood pressure
No Clinical manifestation of liver dysfunction or elevated alanine aminotransferase/aspartate ami- notransferase levels exceeding 2 times the upper limit of normal values
GFR glomerular filtration rate higher than ml/min/1.73m2-60
No history of systemic corticosteroids using
Not using of alcoholic substances
No history of Conditions affecting the absorption of oral drugs (e.g., post gastrectomy and malabsorption syndrome)
No history of using metformin in the last 30 days

Exclusion Criteria

Injecting of corticosteroids in the knee within the study
Estimated glomerular filtration rate of less than 60 ml/min/1.73 m2;
Allergic to metformin hydrochloride;
Severe knee trauma during study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
WOMAC INDEX of osteoarthritis. Timepoint: evaluation of WOMAC index before the study and 4 month later. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire.

Secondary Outcome Measures

Name	Time	Method
The Visual Analogue Scale (VAS) pain score. Timepoint: before the start of the intervention and four consecutive month after the start of the intervention. Method of measurement: The Visual Analogue Scale (VAS) pain score 0-10.