Introduction With an increasing prevalence of citizens of older age and with overweight, the health issues related to knee osteoarthritis (OA) will intensify. Weight loss is considered a primary management strategy in patients with concomitant overweight and knee OA. However, there are no widely available and feasible methods to sustain weight loss in patients with overweight and knee OA. The present protocol describes a randomised controlled trial evaluating the efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide in a 3 mg/day dosing in patients with overweight and knee OA.
Methods and analysis 150 volunteer adult patients with overweight or obesity and knee OA will participate in a randomised, double-blind, placebo-controlled, parallel-group and single-centre trial. The participants will partake in a run-in diet intervention phase (week −8 to 0) including a low calorie diet and dietetic counselling. At week 0, patients will be randomised to either liraglutide 3 mg/day or liraglutide placebo 3 mg/day for 52 weeks as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. The co-primary outcomes are changes in body weight and the Knee Injury and Osteoarthritis Outcome Score pain subscale from week 0 to week 52.
Ethics and dissemination The trial has been approved by the regional ethics committee in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. An external monitoring committee (The Good Clinical Practice Unit at Copenhagen University Hospitals) will oversee the trial. The results will be presented at international scientific meetings and through publications in peer-reviewed journals.
Trial registration numbers 2015-005163-16, NCT02905864, U1111-1171-4970
Based on protocol version V.6; 30 January 2017, 15:30 hours
- weight loss
- dietary intervention
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Contributors HG, EEW, MH, HB, RC, MPB, FKK, MH, AA, EMB and LEK have contributed by conceptualising, designing, writing, reviewing and approving the protocol for this trial. AO, MUR, CB, CD, BLH and KE have contributed by writing, reviewing and approving the protocol and are all part of the acquisition of data from the trial. Moreover, all authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding This work was supported by Novo Nordisk A/S, both financially and through the delivery of active and placebo medicine, and by The Cambridge Weight Plan through the delivery of dietary supplements. The trial is an investigator-initiated study, initiated by the primary investigator Henrik Gudbergsen and the sponsor-investigator Henning Bliddal. In addition, this work was supported by a core grant from the Oak Foundation (OCAY-13-309) given to the Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg.
Competing interests HG has received speaker fees from Pfizer and MSD. MB has received speaker fees from Esaote, AbbVie and UCB. FKK has received lecture fees from, participated in advisory boards of and/or consulted for Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, MSD/Merck, Novo Nordisk, Sanofi and Zealand Pharma. AA is member of advisory boards/consultant for Acino, Switzerland, BioCare Copenhagen, DK, Gelesis, USA, Groupe Éthique et Santé, France, McCain Foods Limited, USA, Novo Nordisk, DK, Pfizer, USA, Saniona, DK, Weight Watchers, USA and Zaluvida, Switzerland. He is recipient of travel grants and honoraria as speaker for a wide range of Danish and international concerns. Commercial interests: co-owner and member of the Board of the consultancy company Dentacom Aps, Denmark (2005). Co-founder and co-owner of UCPH spin-outs Mobile Fitness A/S (2005), Flaxslim ApS (were also member of Board, 2015, and Personalized Weight Management Research Consortium ApS (Gluco-diet.dk, 2017). Co-inventor of a number of patents owned by UCPH, in accordance with Danish law. AA is not advocate or activist for specific diets, and is not strongly committed to any specific diet, for example, veganism, Atkins diet, gluten-free diet, high animal protein diet or dietary supplements. LEK has received fees for speaking and consultancy from Pfizer, AbbVie, Amgen, Sanofi, UCB, Celgene, BMS, Biogen, Novo Nordisk, MSD, Novartis, Eli Lilly and Janssen Pharmaceuticals.
Ethics approval The trial is approved by the regional ethics committee in the Capital Region of Denmark; approval ID H-16019969.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Once the trial has been completed data and information about the study may be accessed by contacting the corresponding author after obtaining and documenting legitimate approval from the Danish data authorities and to the extent possible according to Danish national law.
Correction notice This article has been corrected since it was published. Author name has been changed from Filip K Krag Knop to Filip Krag Knop.
Patient consent for publication Not required.
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