A randomised, double blind, placebo-controlled, parallel group, and single-centre trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis. Patients will be subjected to 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 receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Department of Rheumatology
Frederiksberg, Capital Region, Denmark
Change in body weight
One of two co-primary outcomes
Time frame: Week 0 to 52
KOOS pain subscale
Two of two co-primary outcomes. The Knee injury and Osteoarthritis Outcome Score (KOOS); the pain subscale (9 items)
Time frame: Week 0 to 52
KOOS symptom subscale
Knee injury and Osteoarthritis Outcome Score (KOOS); the symptoms subscale (7 items)
Time frame: Week 0 to 52
KOOS ADL subscale
Knee injury and Osteoarthritis Outcome Score (KOOS); the Activities of Daily Living (ADL) subscale (17 items)
Time frame: Week 0 to 52
KOOS sport and recreation subscale
Knee injury and Osteoarthritis Outcome Score (KOOS); the sport and recreation subscale (5 items)
Time frame: Week 0 to 52
KOOS health related QoL subscale
Knee injury and Osteoarthritis Outcome Score (KOOS); the health related quality of life (QoL) subscale (4 items)
Time frame: Week 0 to 52
Change in total score in the ICOAP questionnaire
The Intermittent and Constant Osteoarthritis Pain questionnaire (ICOAP); 11 items
Time frame: Week 0 to 52
Change in the constant pain subscale in the ICOAP questionnaire
The Intermittent and Constant Osteoarthritis Pain questionnaire (ICOAP); 5 items
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Time frame: Week 0 to 52
Change in the intermittent pain subscale in the ICOAP questionnaire
The Intermittent and Constant Osteoarthritis Pain questionnaire (ICOAP); 6 items
Time frame: Week 0 to 52
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale; 5 items
Time frame: Week 0 to 52
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness subscale
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness subscale; 2 items
Time frame: Week 0 to 52
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function subscale
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function subscale; 17 items
Time frame: Week 0 to 52
Proportion of participants with ≥5% weight loss
The proportion of patients with or with more than a 5% weight loss 52 weeks after randomization
Time frame: Week 0 to 52
Proportion of participants with ≥10% weight loss
The proportion of patients with or with more than a 10% weight loss 52 weeks after randomization
Time frame: Week 0 to 52
Change in BMI
Change in body mass index 52 weeks after randomization
Time frame: Week 0 to 52
Change in waist circumference
Change in waist circumference 52 weeks after randomization
Time frame: Week 0 to 52
Change in waist/hip circumference ratio
Change in the ratio waist circumference/hip circumference 52 weeks after randomization
Time frame: Week 0 to 52