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Completed

NCT Number: NCT02928471

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Body Weight Joint Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Parker Institute and Department of Radiology at Bispebjerg and Frederiksberg Hospital

Frederiksberg, Capital Region, 2000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Same as parent trial (NCT02905864)

Further Exclusion Criteria

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

Treatment and study plan

Intensive dietary intervention

Dietary Supplement

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.

Primary outcomes

  1. Change in the degree of inflammation in the knee-joint (DCE-MRI)

    Time frame: 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 outcomes

  1. Change in the degree of inflammation in the knee-joint (CE-MRI)

    Time frame: 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.)

  2. Change in the degree of inflammation in the knee-joint (MRI)

    Time frame: 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)

  3. Change in cartilage composition

    Time frame: Week -8 to 0

    Change will be assessed via T2-maps of cartilage in the weight-bearing parts of the knee-joint (ROI)

  4. Change in bone marrow lesions (BML)

    Time frame: Week -8 to 0

    Change will be assessed via the MRI knee scoring system MOAKS; BML sum-score

  5. Prediction of clinical symptoms (KOOS pain) by the level of crystal deposition on dual-energy CT at week 0

    Time frame: Week 0

    Crystal deposition will be evaluated via dual-energy CT

Sponsors and collaborators

Lead sponsor

Henrik Gudbergsen

Other

Registry information

Official study 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)

Acronym: IM-LOSEIT-I

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 10, 2016
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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