Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02928679 |
Date of registration:
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07/10/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis; Weight Maintenance
IM-LOSEIT-II |
Scientific title:
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Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis Following Liraglutide Treatment, Investigating the Impact on Inflammation |
Date of first enrolment:
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November 2016 |
Target sample size:
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150 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02928679 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Denmark
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Same as parent trial (NCT02905864)
Further Exclusion Criteria:
- Same as parent trial (NCT02905864)
- Usual exclusion criteria for MRI (i.e. pacemakers etc.)
Age minimum:
18 Years
Age maximum:
74 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Obesity
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Osteoarthritis
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Intervention(s)
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Drug: Liraglutide 3 mg (Saxenda)
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Drug: Liraglutide 3 mg placebo
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Primary Outcome(s)
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Change in the degree of inflammation in the knee-joint (DCE-MRI)
[Time Frame: Week 0 to 52]
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Secondary Outcome(s)
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Change in cartilage composition
[Time Frame: Week 0 to 52]
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Change in bone marrow lesions
[Time Frame: Week 0 to 52]
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Change in the degree of inflammation in the knee-joint (CE-MRI)
[Time Frame: Week 0 to 52]
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Change in the degree of inflammation in the knee-joint (MRI)
[Time Frame: Week 0 to 52]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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