Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis Following a Significant Weight Loss, Investigating the Impact on Inflammation (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)
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Henrik Gudbergsen
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change in the degree of inflammation in the knee-joint (DCE-MRI)
Overview
Brief Summary
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). In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counseling, after which. 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 substudy aims to investigate any changes in MRI associated with the initial 8-week weight loss intervention, and the value of CT scans in predicting the effect of weight loss.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Same as parent trial (NCT02905864)
- •Further Exclusion Criteria
- •Same as parent trial (NCT02905864)
- •Usual exclusion criteria for MRI (i.e. pacemakers etc.)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in the degree of inflammation in the knee-joint (DCE-MRI)
Time Frame: Week -8 to 0
Change will be assessed via a dynamic contrast enhanced MRI evaluation of corpus hoffa (Ballegaard C et al. and Riis RG et al.)
Secondary Outcomes
- Change in the degree of inflammation in the knee-joint (MRI)(Week -8 to 0)
- Change in cartilage composition(Week -8 to 0)
- Change in the degree of inflammation in the knee-joint (CE-MRI)(Week -8 to 0)
- Prediction of clinical symptoms (KOOS pain) by the level of crystal deposition on dual-energy CT at week 0(Week 0)
- Change in bone marrow lesions (BML)(Week -8 to 0)
Investigators
Henrik Gudbergsen
MD, PhD
Parker Research Institute