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Metformin for knee osteoarthritis with obesity: study protocol for a randomised, double-blind, placebo-controlled trial.

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العنوان: Metformin for knee osteoarthritis with obesity: study protocol for a randomised, double-blind, placebo-controlled trial.
المؤلفون: Lim YZ; School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria 3004, Australia., Wang Y; School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria 3004, Australia., Urquhart DM; School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria 3004, Australia., Estee MM; School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria 3004, Australia., Wluka AE; School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria 3004, Australia., Heritier S; School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria 3004, Australia., Cicuttini FM; School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria 3004, Australia flavia.cicuttini@monash.edu.
المصدر: BMJ open [BMJ Open] 2023 Dec 09; Vol. 13 (12), pp. e079489. Date of Electronic Publication: 2023 Dec 09.
نوع المنشور: Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
مواضيع طبية MeSH: Osteoarthritis, Knee*/complications , Osteoarthritis, Knee*/drug therapy, Humans ; Overweight/complications ; Quality of Life ; Double-Blind Method ; Pain/complications ; Obesity/complications ; Obesity/drug therapy ; Treatment Outcome ; Randomized Controlled Trials as Topic
مستخلص: Introduction: Over half of the populations with knee osteoarthritis (OA) have obesity. These individuals have many other shared metabolic risk factors. Metformin is a safe, inexpensive, well-tolerated drug that has pleiotropic effects, including structural protection, anti-inflammatory and analgesic effects in OA, specifically the knee. The aim of this randomised, double-blind, placebo-controlled trial is to determine whether metformin reduces knee pain over 6 months in individuals with symptomatic knee OA who are overweight or obese.
Methods and Analysis: One hundred and two participants with symptomatic knee OA and overweight or obesity will be recruited from the community in Melbourne, Australia, and randomly allocated in a 1:1 ratio to receive either metformin 2 g or identical placebo daily for 6 months. The primary outcome is reduction of knee pain [assessed by 100 mm Visual Analogue Scale (VAS)] at 6 months. The secondary outcomes are OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) responder criteria [Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, function and participant's global assessment (VAS)] at 6 months; change in knee pain, stiffness, function using WOMAC at 6 months and quality of life at 6 months. Adverse events will be recorded. The primary analysis will be by intention to treat, including all participants in their randomised groups.
Ethics and Dissemination: Ethics approval has been obtained from the Alfred Hospital Ethics Committee (708/20) and Monash University Human Research Ethics Committee (28498). Written informed consent will be obtained from all the participants. The findings will be disseminated through peer-review publications and conference presentations.
Trial Registration Number: ACTRN12621000710820 .
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)
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فهرسة مساهمة: Keywords: Knee; Obesity; Randomized Controlled Trial
تواريخ الأحداث: Date Created: 20231209 Date Completed: 20231216 Latest Revision: 20240201
رمز التحديث: 20240201
مُعرف محوري في PubMed: PMC10729261
DOI: 10.1136/bmjopen-2023-079489
PMID: 38070903
قاعدة البيانات: MEDLINE
الوصف
تدمد:2044-6055
DOI:10.1136/bmjopen-2023-079489