Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Loss

Study Overview
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Brief Summary
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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). This substudy aims to investigate any changes in biomarkers associated with the initial 8-week weight loss intervention

Detailed Description
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In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counselling, after which they 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.

Official Title
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Biomarkers in Obese Patients With Knee Osteoarthritis Following a Significant Weight Loss

Conditions
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Osteoarthrtis, Obesity

Intervention / Treatment
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* Dietary Supplement: Dietary Supplement: Dietary Supplement: Intensive dietary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Same as parent trial (NCT02905864) Exclusion Criteria: Same as parent trial (NCT02905864)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive dietary intervention<br>Supervised dietary weight loss program lasting 8 weeks | Dietary Supplement: Dietary Supplement: Dietary Supplement: Intensive dietary intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in collagen II degradation fragment α-C2M | Blood sampling | Week -8 to 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in collagen II degradation fragment β-C2M | Blood sampling | Week -8 to 0 | 
| Change in non-coding RNA type snoRNAs U38 and U48 | Blood sampling | Week -8 to 0 | 
| Change in miRNA-454 | Blood sampling | Week -8 to 0 | 
| Change in miRNA let-7e | Blood sampling | Week -8 to 0 | 
| Change in Nesfatin-1 | Blood sampling | Week -8 to 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthrtis, Obesity, Liraglutide 3 mg, Liraglutide, Biomarkers