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IRCT20150202020908N2 IRCT 2020-12-24 Shiraz University of Medical Sciences Evaluation of the molecular effects of metformin and improvement of symptoms in osteoarthritis patients mTOR Evaluation of interaction of mTOR signaling pathway and improvement of symptoms in osteoarthritis patients treated with metformin 2019-06-22 anticipated 100 Complete https://irct.ir/trial/38959 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Other design features: The study was performed on patients who received medication in one group and did not receive medication in the other, Blinding description: The lead researcher conducting research experiments on the collected samples is blinded and unaware of whether or not metformin was used by participants. 2-3 Osteoarthritis. Intervention 1: Intervention group: Osteoarthritis patients with high-BMI who take metformin in addition to their previous treatment. In the first week, 500 mg daily, the second week 1000 mg daily and then 1500 mg daily until the end of the study for 16 weeks, metformin is given. Clinical evaluation is done by the physician (using the WOMAC questionnaire) and sampling at weeks 0 and 16. Intervention 2: Control group: Osteoarthritis patients with high-BMI who do not take metformin and continue their previous treatment. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of data
public Mohammad Tahami
Shahid Chamran Hospital., Chamran Blvd
Shiraz Iran (Islamic Republic of) 7146864685 +98 71 3623 4504 mohammad.tahami@yahoo.com Shiraz University of Medical Sciences scientific Negar Firouzabadi
Karafarin Ave., Rokn abad Town., Km 5 Shiraz-Isfahan Highway
Shiraz Iran (Islamic Republic of) 7146864685 +98 71 3242 4128 Firouzabadi@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Obesity Inflammatory osteoarthritis 18 years no limit Both Autoimmune disease Age under 18 years old Cancer Inflammatory bowel disease Diabetes mellitus M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Intervention group: Osteoarthritis patients with high-BMI who take metformin in addition to their previous treatment. In the first week, 500 mg daily, the second week 1000 mg daily and then 1500 mg daily until the end of the study for 16 weeks, metformin is given. Clinical evaluation is done by the physician (using the WOMAC questionnaire) and sampling at weeks 0 and 16. Control group: Osteoarthritis patients with high-BMI who do not take metformin and continue their previous treatment. WOMAC questionnaire score. Timepoint: At the beginning of the study (before the intervention) and 16 weeks after starting metformin. Method of measurement: WOMAC questionnaire. Shiraz University of Medical Sciences Approved 2019-10-26 Ethics committee of Shiraz University of Medical Sciences Immam hossein Square., Karim Khan Zand Blvd. Shiraz Fars Iran (Islamic Republic of)