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

Completed

• Conditions: Obesity; Osteoarthritis
• Interventions: Dietary Supplement: Intensive dietary intervention

• Registration Number: NCT02928471
• Lead Sponsor: Henrik Gudbergsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-07
• Study First Posted: 2016-10-10
• Study Start: 2016-11
• Primary Completion: 2019-02
• Status Verified: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intensive dietary intervention	Intensive dietary intervention	Supervised dietary weight loss program lasting 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in the degree of inflammation in the knee-joint (DCE-MRI)	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 Outcome Measures

Name	Time	Method
Change in the degree of inflammation in the knee-joint (MRI)	Week -8 to 0	Change will be assessed via a conventional MRI evaluation of the level of synovitis and effusion (combined) in the knee-joint (MOAKS)
Change in cartilage composition	Week -8 to 0	Change will be assessed via T2-maps of cartilage in the weight-bearing parts of the knee-joint (ROI)
Change in the degree of inflammation in the knee-joint (CE-MRI)	Week -8 to 0	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.)
Prediction of clinical symptoms (KOOS pain) by the level of crystal deposition on dual-energy CT at week 0	Week 0	Crystal deposition will be evaluated via dual-energy CT
Change in bone marrow lesions (BML)	Week -8 to 0	Change will be assessed via the MRI knee scoring system MOAKS; BML sum-score

Trial Locations

Locations (1)

The Parker Institute and Department of Radiology at Bispebjerg and Frederiksberg Hospital; 🇩🇰 Frederiksberg, Capital Region, Denmark