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). This substudy aims to investigate any changes in biomarkers associated with the initial 8-week weight loss intervention
In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counselling, after which they 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
NA
Purpose
TREATMENT
Masking
NONE
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
Frederiksberg, Capital Region, Denmark
Change in collagen II degradation fragment α-C2M
Blood sampling
Time frame: Week -8 to 0
Change in collagen II degradation fragment β-C2M
Blood sampling
Time frame: Week -8 to 0
Change in non-coding RNA type snoRNAs U38 and U48
Blood sampling
Time frame: Week -8 to 0
Change in miRNA-454
Blood sampling
Time frame: Week -8 to 0
Change in miRNA let-7e
Blood sampling
Time frame: Week -8 to 0
Change in Nesfatin-1
Blood sampling
Time frame: Week -8 to 0
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