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

Obesity Clinical Trial

— IM-LOSEIT-I  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02928471
• Other study ID #: 137.03
• Status: Completed
• Start date: November 2016
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: Parker Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• Same as parent trial (NCT02905864)

Further Exclusion Criteria

• Same as parent trial (NCT02905864)

• Usual exclusion criteria for MRI (i.e. pacemakers etc.)

Related Conditions & MeSH terms

• Obesity
• Osteoarthritis
• Osteoarthritis, Knee
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
Denmark	The Parker Institute and Department of Radiology at Bispebjerg and Frederiksberg Hospital	Frederiksberg	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Henrik Gudbergsen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in bone marrow lesions (BML)	Change will be assessed via the MRI knee scoring system MOAKS; BML sum-score	Week -8 to 0
Secondary	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