This is sub-study to 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 (NCT02905864). In the parent trial 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. This sub-study of the parent trial only involves an additional assessment of skin auto fluorescence (AGE concentration) in the preallocation phase and in the main trial phase, i.e. from enrollment (defined as signature of informed consent) to treatment allocation (visits -Tx and T0 in the parent trial visit schedule) and from allocation to end of trial (visits T0 and T15 in the parent trial visit schedule).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Dose escalation scheme: Initial dosage of 0.6 mg per day, escalated bi-weekly by 0.6 mg to 3 mg per day over a total of 8 weeks
Dose escalation scheme: Initial dosage of a 0.6 mg drug equivalent volume per day, escalated bi-weekly by an 0.6 mg drug equivalent volume per day to a 3 mg drug equivalent volume per day over a total of 8 weeks.
Department of Rheumatology
Frederiksberg, Capital Region, Denmark
Change in advanced glycation end products in the skin
advanced glycation end products levels will be measured on the skin of the volar side of the forearm using skin auto fluorescence
Time frame: week 0 to 52
Change in advanced glycation end products in the skin
advanced glycation end products levels will be measured on the skin of the volar side of the forearm using skin auto fluorescence.
Time frame: week -8 to 0 (pre-randomisation weight loss intervention)
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