Changes in Skin Autoflouresence Following Weight Loss and Maintenance Using Liraglutide in Knee Osteoarthritis

Sponsor
Parker Research Institute
Study ID
NCT02910570
Phase
PHASE4
Status
Completed

Conditions

  • Osteoarthritis, Knee

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide 3 mg (Saxenda) — DRUG
    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
  • Liraglutide 3 mg placebo — DRUG
    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.

Study Details

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).

Key Dates

Start date
Nov 30, 2016
Status verified
Mar 2019
Primary completion
Feb 28, 2019
Completion
Mar 31, 2019

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in advanced glycation end products in the skin [ Time Frame: week 0 to 52 ]

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