Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis; Weight Loss

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Osteoarthritis, Obesity

Intervention / Treatment
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* Dietary Supplement: Intensive dietary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Same as parent trial (NCT02905864) Further Exclusion Criteria Same as parent trial (NCT02905864) Usual exclusion criteria for MRI (i.e. pacemakers etc.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intensive dietary intervention<br>Supervised dietary weight loss program lasting 8 weeks. | Dietary Supplement: Intensive dietary intervention<br>* Participants receive a hypo-caloric formula diet containing 800 to 1,000 kcal/day. The formula diet consists of ready-to-use meal bars and powders to mix with water to make shakes, soups, or porridge. The weight loss programme consists of an 8-week period with full meal replacement by a standard liquid energy intake protocol. To facilitate compliance with the programme, participants will be scheduled for weekly facility-based group sessions with 6-8 participants led by a dietician. The recommendations for daily nutrient intake will be met.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the degree of inflammation in the knee-joint (DCE-MRI) | Change will be assessed via a dynamic contrast enhanced MRI evaluation of corpus hoffa (Ballegaard C et al. and Riis RG et al.) | Week -8 to 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the degree of inflammation in the knee-joint (CE-MRI) | Change will be assessed via a static contrast enhanced MRI evaluation of the level of synovitis in the knee-joint (11 sites scored 0-2, ad modum Guermazi et al.) | Week -8 to 0 | 
| Change in the degree of inflammation in the knee-joint (MRI) | Change will be assessed via a conventional MRI evaluation of the level of synovitis and effusion (combined) in the knee-joint (MOAKS) | Week -8 to 0 | 
| Change in cartilage composition | Change will be assessed via T2-maps of cartilage in the weight-bearing parts of the knee-joint (ROI) | Week -8 to 0 | 
| Change in bone marrow lesions (BML) | Change will be assessed via the MRI knee scoring system MOAKS; BML sum-score | Week -8 to 0 | 
| Prediction of clinical symptoms (KOOS pain) by the level of crystal deposition on dual-energy CT at week 0 | Crystal deposition will be evaluated via dual-energy CT | Week 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liraglutide, Liraglutide 3 mg, Osteoarthritis, Obesity, Magnetic resonance imaging, Computed tomography, Dynamic contrast enhanced MRI