The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Patients With Knee Osteoarthritis
- Registration Number
- NCT04767841
- Lead Sponsor
- Sadat City University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Primary osteoarthritis Patients recruited were between 30 to 60 years of age, with X-ray confirmed Kellgren-Lawrence grade13 II or III severity primary tibiofemoral OA, according to the American College of Rheumatology criteria.
Those patients were excluded from the present study who:
- were of age less than 30 years or more than 60 years
- presented with active concomitant gastroduodenal disorders, hepatic and renal impairment within last 30 days prior to receiving the study drug
- were diagnosed to have any inflammatory arthritis, gout or acute trauma of the knee, hip or spine; accompanying OA of the hip of sufficient severity to interfere with the functional assessment of the knee
- had previous or ongoing treatment with oral SYSDOA (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics; were having active cardiac lesion or hypertension, were pregnant females and those who were planning their pregnancy during the study
- were having a known hypersensitivity to the used medications
- have persistent diarrhoea or laxative use; severe gastrointestinal disorders, severe obesity, severe parenchymal organ disease, or anaemia (haemoglobin< 10.0 g/ dl or haematocrit < 30%).
- Patients who received oral, intramuscular, intraarticular or soft tissue injections of corticosteroids within last eight weeks before receiving the first dose of the study medication, or had undergone joint lavage and arthroscopic procedures in the previous 6 months, were also excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo tablet daily plus Celecoxib 200mg capsule Metformin Metformin Metformin 1000 mg daily plus Celecoxib 200mg capsule
- Primary Outcome Measures
Name Time Method Visual Analogue scale assessment of pain week 12 the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment
- Secondary Outcome Measures
Name Time Method AMPK expression 12 weeks AMPK gene expression
WOMAC change week 12 the change of WOMAC Osteoarthritis Index from baseline to posttreatment
Serum level Tumor necrosis factor- alpha (TNF-α) 12 weeks Serum level Tumor necrosis factor- alpha (TNF-α)
the change of Short Form 36 Questionnaire (SF-36) score from baseline to posttreatment week 12 The SF-36 is a generic instrument to assess health-related quality of life. It consists of 36 questions and assesses 8 dimensions: physical functioning, role physical, pain index, general health, vitality, social functioning, role emotional, and mental health index. It also provides 2 summary measures of physical and mental components. The SF-36 score ranges from 0 to 100, with higher scores indicating better health status.
IL-17 12 weeks Serum levels of IL-17
Adverse drug reaction 12 weeks Clinical side effects
Serum levels of IL-1β 12 weeks Serum levels of IL-1β
Trial Locations
- Locations (1)
Faculty of Pharmacy
🇪🇬Shibīn Al Kawm, Menoufia, Egypt