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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive dietary intervention | Supervised dietary weight loss program lasting 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive dietary intervention | Dietary Supplement | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Further Exclusion Criteria
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Participants eligible for parent trial (NCT02905864), i.e. overweight/obese individuals with knee osteoarthritis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Parker Institute and Department of Radiology at Bispebjerg and Frederiksberg Hospital | Frederiksberg | Capital Region | 2000 | Denmark |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
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 |
| D050177 |
| Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |