Ultrasound of the Knee in Obese Patients With Knee Osteoarthritis; Weight Loss (US-LOSEIT-I)
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|ClinicalTrials.gov Identifier: NCT02931370|
Recruitment Status : Completed
First Posted : October 13, 2016
Last Update Posted : March 25, 2019
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 Ultrasound (US) measures associated with the initial 8-week weight loss intervention.
|Condition or disease||Intervention/treatment|
|Osteoarthritis Obesity||Dietary Supplement: Dietary Supplement: Intensive dietary intervention|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Ultrasound of the Knee in Obese Patients With Knee Osteoarthritis Following a Significant Weight Loss, Investigating the Impact on Inflammation|
|Study Start Date :||November 2016|
|Actual Primary Completion Date :||February 2019|
|Actual Study Completion Date :||March 2019|
Intensive dietary intervention
Supervised dietary weight loss program lasting 8 weeks
Dietary Supplement: Dietary Supplement: Intensive 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.
- Change in the degree of inflammation in the knee-joint (Greyscale-score) [ Time Frame: Week -8 to 0 ]Change will be assessed by grey-scale ultrasound in the suprapatellar, the medial, and the lateral recess´ (sum-score (0-9), derived from these three positions)
- Change in knee-joint effusion [ Time Frame: Week -8 to 0 ]Change in effusion will be assessed via the US knee OA MUS score (Riecke BF et al.)
- Change in the degree of inflammation in the knee-joint (Greyscale-size) [ Time Frame: Week -8 to 0 ]Change will be assessed by grey-scale ultrasound in the suprapatellar, the medial, and the lateral recess´ (sum of size-scores (mm) of these three positions)
- Change in the degree of inflammation in the knee-joint (Doppler-score) [ Time Frame: Week -8 to 0 ]Change will be assessed by Doppler ultrasound in the suprapatellar, the medial, and the lateral recess´ (sum-score (0-9), derived from these three positions)
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): NCT02931370
|The Parker Institute and Department of Radiology at Bispebjerg and Frederiksberg Hospital|
|Frederiksberg, Capital Region, Denmark, 2000|