Obesity, Osteoarthrtis
Conditions
Keywords
Osteoarthrtis, Obesity, Liraglutide 3 mg, Liraglutide, Biomarkers
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). This substudy aims to investigate any changes in biomarkers associated with the initial 8-week weight loss intervention
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTDietary 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.
Sponsors
Henrik Gudbergsen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Same as parent trial (NCT02905864)
Exclusion criteria
* Same as parent trial (NCT02905864)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in collagen II degradation fragment α-C2M | Week -8 to 0 | Blood sampling |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in collagen II degradation fragment β-C2M | Week -8 to 0 | Blood sampling |
| Change in non-coding RNA type snoRNAs U38 and U48 | Week -8 to 0 | Blood sampling |
| Change in miRNA-454 | Week -8 to 0 | Blood sampling |
| Change in miRNA let-7e | Week -8 to 0 | Blood sampling |
| Change in Nesfatin-1 | Week -8 to 0 | Blood sampling |
Countries
Denmark
Outcome results
None listed