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 (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 any changes in Ultrasound (US) measures associated with the initial 8-week weight loss intervention.
Study Type
OBSERVATIONAL
Enrollment
200
Participants receive a hypo-caloric formula diet containing 800 to 1,000 kcal/day. The formula diet consists of ready-to-use meal bars and powders to mix with water to make shakes, soups, or porridge. The weight loss programme consists of an 8-week period with full meal replacement by a standard liquid energy intake protocol. To facilitate compliance with the programme, participants will be scheduled for weekly facility-based group sessions with 6-8 participants led by a dietician. The recommendations for daily nutrient intake will be met.
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 in the suprapatellar, the medial, and the lateral recess´ (sum-score (0-9), derived from these three positions)
Time frame: Week -8 to 0
Change in knee-joint effusion
Change in effusion will be assessed via the US knee OA MUS score (Riecke BF et al.)
Time frame: Week -8 to 0
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 -8 to 0
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 -8 to 0
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