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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02928471

Acronym

IM-LOSEIT-I

Enrollment

200

Registered

2016-10-10

Start date

2016-11-30

Completion date

2019-03-31

Last updated

2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Osteoarthritis

Keywords

Liraglutide, Liraglutide 3 mg, Osteoarthritis, Obesity, Magnetic resonance imaging, Computed tomography, Dynamic contrast enhanced MRI

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.

Interventions

DIETARY_SUPPLEMENTIntensive 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

Healthy volunteers

Inclusion criteria

* Same as parent trial (NCT02905864) Further

Exclusion criteria

* Same as parent trial (NCT02905864) * Usual

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026