Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis: Protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial

Henrik Gudbergsen*, Marius Henriksen, Eva Ejlersen Wæhrens, Anders Overgaard, Henning Bliddal, Robin Christensen, Mikael Ploug Boesen, Filip K.Krag Knop, Arne Astrup, Marianne Uggen Rasmussen, Cecilie Bartholdy, Cecilie Daugaard, Else Marie Bartels, Karen Ellegaard, Berit Lilienthal Heitmann, Lars Erik Kristensen

*Corresponding author for this work

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Abstract

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.

Original languageEnglish
Article numbere024065
JournalB M J Open
Volume9
Issue number5
Number of pages12
ISSN2044-6055
DOIs
Publication statusPublished - 5. May 2019

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Knee Osteoarthritis
Placebos
Dietetics
Computer Security
Knee Injuries
Caloric Restriction
Ethics Committees
Denmark
Ethics
Publications
Liraglutide
Counseling
Volunteers
Randomized Controlled Trials
Diet
Safety
Food
Health

Keywords

  • dietary intervention
  • knee
  • liraglutide
  • osteoarthritis
  • overweight
  • weight loss

Cite this

Gudbergsen, Henrik ; Henriksen, Marius ; Wæhrens, Eva Ejlersen ; Overgaard, Anders ; Bliddal, Henning ; Christensen, Robin ; Boesen, Mikael Ploug ; Knop, Filip K.Krag ; Astrup, Arne ; Rasmussen, Marianne Uggen ; Bartholdy, Cecilie ; Daugaard, Cecilie ; Bartels, Else Marie ; Ellegaard, Karen ; Heitmann, Berit Lilienthal ; Kristensen, Lars Erik. / Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis : Protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial. In: B M J Open. 2019 ; Vol. 9, No. 5.
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title = "Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis: Protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial",
abstract = "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.",
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Gudbergsen, H, Henriksen, M, Wæhrens, EE, Overgaard, A, Bliddal, H, Christensen, R, Boesen, MP, Knop, FKK, Astrup, A, Rasmussen, MU, Bartholdy, C, Daugaard, C, Bartels, EM, Ellegaard, K, Heitmann, BL & Kristensen, LE 2019, 'Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis: Protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial', B M J Open, vol. 9, no. 5, e024065. https://doi.org/10.1136/bmjopen-2018-024065

Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis : Protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial. / Gudbergsen, Henrik; Henriksen, Marius; Wæhrens, Eva Ejlersen; Overgaard, Anders; Bliddal, Henning; Christensen, Robin; Boesen, Mikael Ploug; Knop, Filip K.Krag; Astrup, Arne; Rasmussen, Marianne Uggen; Bartholdy, Cecilie; Daugaard, Cecilie; Bartels, Else Marie; Ellegaard, Karen; Heitmann, Berit Lilienthal; Kristensen, Lars Erik.

In: B M J Open, Vol. 9, No. 5, e024065, 05.05.2019.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis

T2 - Protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial

AU - Gudbergsen, Henrik

AU - Henriksen, Marius

AU - Wæhrens, Eva Ejlersen

AU - Overgaard, Anders

AU - Bliddal, Henning

AU - Christensen, Robin

AU - Boesen, Mikael Ploug

AU - Knop, Filip K.Krag

AU - Astrup, Arne

AU - Rasmussen, Marianne Uggen

AU - Bartholdy, Cecilie

AU - Daugaard, Cecilie

AU - Bartels, Else Marie

AU - Ellegaard, Karen

AU - Heitmann, Berit Lilienthal

AU - Kristensen, Lars Erik

PY - 2019/5/5

Y1 - 2019/5/5

N2 - 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.

AB - 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.

KW - dietary intervention

KW - knee

KW - liraglutide

KW - osteoarthritis

KW - overweight

KW - weight loss

U2 - 10.1136/bmjopen-2018-024065

DO - 10.1136/bmjopen-2018-024065

M3 - Journal article

C2 - 31061017

AN - SCOPUS:85065397420

VL - 9

JO - B M J Open

JF - B M J Open

SN - 2044-6055

IS - 5

M1 - e024065

ER -