Changes in Skin Autoflouresence Following Weight Loss and Maintenance Using Liraglutide in Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT02910570|
Recruitment Status : Completed
First Posted : September 22, 2016
Last Update Posted : March 25, 2019
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).
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Drug: Liraglutide 3 mg (Saxenda) Drug: Liraglutide 3 mg placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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)|
|Study Start Date :||November 2016|
|Actual Primary Completion Date :||February 2019|
|Actual Study Completion Date :||March 2019|
Experimental: Liraglutide 3 mg
Subjects will be up titrated to liraglutide 3 mg QD and stay on that dose for the remainder of the 52-week drug intervention period.
Drug: Liraglutide 3 mg (Saxenda)
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
Placebo Comparator: Liraglutide 3 mg placebo
Subjects will be up titrated to liraglutide 3 mg placebo QD and stay on that dose for the remainder of the 52-week drug intervention period.
Drug: Liraglutide 3 mg placebo
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.
- Change in advanced glycation end products in the skin [ Time Frame: week 0 to 52 ]advanced glycation end products levels will be measured on the skin of the volar side of the forearm using skin auto fluorescence
- Change in advanced glycation end products in the skin [ Time Frame: week -8 to 0 (pre-randomisation weight loss intervention) ]advanced glycation end products levels will be measured on the skin of the volar side of the forearm using skin auto fluorescence.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910570
|Department of Rheumatology|
|Frederiksberg, Capital Region, Denmark, 2000|
|Principal Investigator:||Henrik R Gudbergsen, MD, PhD||The Parker Institute|