TY - JOUR
T1 - Metformin for knee osteoarthritis with obesity
T2 - study protocol for a randomised, double-blind, placebo-controlled trial
AU - Lim, Yuan Z.
AU - Wang, Yuanyuan
AU - Urquhart, Donna M.
AU - Estee, Mahnuma Mahfuz
AU - Wluka, Anita E.
AU - Heritier, Stephane
AU - Cicuttini, Flavia M.
N1 - Funding Information:
Ms Molly Bond, Mr Noor Abid, Mr Ashish Dinesh Nair, Dr Benjamin Sutu, Dr Talia Igel, Dr Luigi Zolio and Dr Rushab Shah have been involved in the coordination and/or execution of this study. The study is funded by an Investigator Grant from the National Health and Medical Research Council of Australia (NHMRC APP1194829). YL is the recipient of National Health and Medical Research Council (NHMRC) Clinical Postgraduate Scholarship (#1133903) and Royal Australasian College of Physicians Woolcock Scholarship. YW is the recipient of NHMRC Translating Research into Practice Fellowship (APP1168185). DMU is a recipient of an NHMRC/Medical Research Future Fund (MRFF) Career Development Fellowship (Clinical Level 2 #1142809). MME is the recipient of Bangabandhu Science and Technology Fellowship from Ministry of Science and Technology, Government of the People's Republic of Bangladesh. FC is the recipient of NHMRC Investigator Grant (APP1194829).
Funding Information:
The study is funded by an Investigator Grant from the National Health and Medical Research Council of Australia (NHMRC APP1194829). YL is the recipient of National Health and Medical Research Council (NHMRC) Clinical Postgraduate Scholarship (#1133903) and Royal Australasian College of Physicians Woolcock Scholarship. YW is the recipient of NHMRC Translating Research into Practice Fellowship (APP1168185). DMU is a recipient of an NHMRC/Medical Research Future Fund (MRFF) Career Development Fellowship (Clinical Level 2 #1142809). MME is the recipient of Bangabandhu Science and Technology Fellowship from Ministry of Science and Technology, Government of the People's Republic of Bangladesh. FC is the recipient of NHMRC Investigator Grant (APP1194829).
Publisher Copyright:
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.
PY - 2023/12/9
Y1 - 2023/12/9
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85179646068&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2023-079489
DO - 10.1136/bmjopen-2023-079489
M3 - Article
C2 - 38070903
AN - SCOPUS:85179646068
SN - 2044-6055
VL - 13
JO - BMJ Open
JF - BMJ Open
IS - 12
M1 - e079489
ER -
