Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis; Weight Loss (IM-LOSEIT-I)

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)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Osteoarthritis
• Intervention / Treatment: Dietary supplement: Intensive dietary intervention

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Denmark
  • Capital Region
    • Frederiksberg, Capital Region, Denmark, 2000
      • The Parker Institute and Department of Radiology at Bispebjerg and Frederiksberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants eligible for parent trial (NCT02905864), i.e. overweight/obese individuals with knee osteoarthritis

Description

Inclusion Criteria:

• Same as parent trial (NCT02905864)

Further Exclusion Criteria

• Same as parent trial (NCT02905864)
• Usual exclusion criteria for MRI (i.e. pacemakers etc.)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Intensive dietary intervention; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Henrik Gudbergsen

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: October 7, 2016
• First Submitted That Met QC Criteria: October 7, 2016
• First Posted (Estimate): October 10, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Obesity; Osteoarthritis; Liraglutide; Liraglutide 3 mg; Magnetic resonance imaging; Computed tomography; Dynamic contrast enhanced MRI
• Additional Relevant MeSH Terms: Body Weight; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Body Weight Changes; Osteoarthritis; Osteoarthritis, Knee; Weight Loss
• Other Study ID Numbers: 137.03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No