osteoarthritis of the knee
Conditions
Interventions
Metformin group:Receive metformin (maximum 2000 mg) once daily. The study drug treatment will start at a dose of 500 mg, once daily, taken with dinner. Over 6 weeks, the dose of the study drug will be
Control group:A placebo at the same dose as the trial drug, once daily.
Sponsors
Honghui Hospital, Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Males and females aged >40 years, who are overweight or obese (body mass index >=25 kg/m^2); 2. Knee pain for at least 6 months, with a pain score >40 mm on a 100 mm visual analog scale (VAS); 3. Meet the clinical criteria for knee osteoarthritis (OA) set by the American College of Rheumatology.
Exclusion criteria
Exclusion criteria: 1.Severe radiographic knee OA (Kellgren-Lawrence grade 4) or severe knee pain (>80 mm on a 100 mm VAS while standing); 2. Any inflammatory arthritis, including rheumatoid arthritis, psoriatic arthritis, crystal-induced arthritis, spondyloarthritis, connective tissue disease-associated arthritis, or reactive arthritis, or severe knee injury; 3.Known or newly diagnosed diabetes mellitus requiring glycemic control or previous adverse reaction to metformin; 4.Index knee surgery (arthroscopic or open surgery) within the past year; 5. Intra-articular injection of hyaluronic acid in the index knee within the past 6 months or corticosteroid injection within the past 3 months; 6. Use of any investigational drug or device within 30 days prior to randomization; 7. Planned index knee replacement or arthroscopy within the next 6 months; 8. Other musculoskeletal, joint, or neurological diseases affecting the function of the lower limbs; 9. Acute or chronic renal or hepatic impairment; 10. Other medical conditions that would preclude participation in the study or relocation; 11. Pregnant, breastfeeding, or women attempting to become pregnant. Hormone replacement therapy or contraceptives are permitted as long as the dose has been stable for at least 30 days prior to entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual analogue scale,VAS ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Western Ontario University and McMaster University Osteoarthritis Index;Brief Health Survey Scale-12,SF-12;PainDETECT ;Imaging Evaluation;General (complete blood count, liver and kidney function), inflammatory biomarkers (C-reactive protein, erythrocyte sedimentation rate, interleukin-6, tumor necrosis factor), blood glucose and lipids, as well as vitamin B12.;the Outcome Measures in Rheumatology–Osteoarthritis Research Society International; | — |
Countries
China
Contacts
Public ContactXu Chao
Honghui Hospital, Xi'an Jiaotong University
Outcome results
None listed