An observational study in Osteoarthritis and Obesity, sponsored by Henrik Gudbergsen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2019-03-25.
Sponsored by Henrik Gudbergsen · Observational
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.
4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 803 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Henrik Gudbergsen is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants eligible for parent trial (NCT02905864), i.e. overweight/obese individuals with knee osteoarthritis
Inclusion Criteria:
Further Exclusion Criteria
Supervised dietary weight loss program lasting 8 weeks.
Dietary Supplement: Intensive dietary intervention
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.
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.)
Time frame: Week -8 to 0
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.)
Time frame: 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)
Time frame: 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)
Time frame: Week -8 to 0
Change in bone marrow lesions (BML)
Change will be assessed via the MRI knee scoring system MOAKS; BML sum-score
Time frame: 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
Time frame: Week 0
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Henrik Gudbergsen