This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (OA) (NCT02905864). In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counseling, after which 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. This substudy aims to investigate the impact of, and subsequent change of, joint inflammation and clinical symptoms, in obese patients with knee osteoarthritis following a randomisation to Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
The Parker Institute and Department of Radiology at Bispebjerg and Frederiksberg Hospital
Frederiksberg, Capital Region, Denmark
Change in the degree of inflammation in the knee-joint (Greyscale-score)
Change will be assessed by grey-scale ultrasound (US) in the suprapatellar, the medial, and the lateral recess´ (sum-score (0-9), derived from these three positions)
Time frame: Week 0 to 52
Change in knee-joint effusion
Change in effusion will be assessed via the US knee OA musculoskeletal ultrasound score (MUS) score (Riecke BF et al.)
Time frame: Week 0 to 52
Change in the degree of inflammation in the knee-joint (Greyscale-size)
Change will be assessed by grey-scale ultrasound in the suprapatellar, the medial, and the lateral recess´ (sum of size-scores (mm) of these three positions)
Time frame: Week 0 to 52
Change in the degree of inflammation in the knee-joint (Doppler-score)
Change will be assessed by Doppler ultrasound in the suprapatellar, the medial, and the lateral recess´ (sum-score (0-9), derived from these three positions)
Time frame: Week 0 to 52
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