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

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ClinicalTrials.gov Identifier: NCT02928679
Recruitment Status : Completed
First Posted : October 10, 2016
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Henrik Gudbergsen, Parker Research Institute

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 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.


Condition or disease Intervention/treatment Phase
Osteoarthritis Obesity Drug: Liraglutide 3 mg (Saxenda) Drug: Liraglutide 3 mg placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis Following Liraglutide Treatment, Investigating the Impact on Inflammation
Study Start Date : November 2016
Actual Primary Completion Date : February 20, 2019
Actual Study Completion Date : March 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Liraglutide 3 mg

Arm description: Subjects will be up titrated to liraglutide 3 mg QD and stay on that dose for the remainder of the 52-week drug intervention period.

Drug: Liraglutide 3 mg QD administered in a 6 mg/mL, 3 mL pen for subcutaneous injection.

Dose escalation scheme: Initial dosage of 0.6 mg per day, escalated bi-weekly by 0.6 mg to 3 mg per day over a total of 8 weeks.

Drug: Liraglutide 3 mg (Saxenda)
Placebo Comparator: Liraglutide 3 mg placebo

Arm description: Subjects will be up titrated to liraglutide 3 mg placebo QD and stay on that dose for the remainder of the 52-week drug intervention period.

Drug: Liraglutide 3 mg placebo QD administered in a 6 mg/mL drug equivalent volumes, 3 mL pen for subcutaneous injection.

Dose escalation scheme: Initial dosage of a 0.6 mg drug equivalent volume per day, escalated bi-weekly by an 0.6 mg drug equivalent volume per day to a 3 mg drug equivalent volume per day over a total of 8 weeks.

Drug: Liraglutide 3 mg placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Same as parent trial (NCT02905864)

Further Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928679


Locations
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Denmark
The Parker Institute and Department of Radiology at Bispebjerg and Frederiksberg Hospital
Frederiksberg, Capital Region, Denmark, 2000
Sponsors and Collaborators
Henrik Gudbergsen

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Responsible Party: Henrik Gudbergsen, MD, PhD, Parker Research Institute
ClinicalTrials.gov Identifier: NCT02928679     History of Changes
Other Study ID Numbers: 137.05
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Henrik Gudbergsen, Parker Research Institute:
Magnetic resonance imaging
Dynamic contrast enhanced MRI
Liraglutide 3 mg
Liraglutide
Obesity
Osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists