Osteoarthritis, Knee Clinical Trial
Official title:
The Association Between Weight Loss With Subsequent Maintenance Using Liraglutide and Changes in Skin Autoflouresence in Overweight or Obese Patients With Knee Osteoarthritis - a Substudy to "Effect of Liraglutide on Body Weight and Pain in Overweight or Obese Patients With Knee Osteoarthritis: A Randomised, Double Blind, Placebo-controlled, Parallel Group, Single-centre Trial" (NCT02905864)
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).
n/a
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