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Completed

NCT Number: NCT02928679

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

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 the impact of, and subsequent change of, joint inflammation, articular cartilage composition, overall knee morphology, and clinical symptoms, in obese patients with knee osteoarthritis following a randomisation to Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.

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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

Interventional

Phase

Phase 4

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

Liraglutide 3 mg (Saxenda)

Drug

Liraglutide 3 mg placebo

Drug

Primary outcomes

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

    Time frame: Week 0 to 52

    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 0 to 52

    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 0 to 52

    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 0 to 52

    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

    Time frame: Week 0 to 52

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

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 Liraglutide Treatment, Investigating the Impact on Inflammation

Acronym: IM-LOSEIT-II

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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