Obesity, Osteoarthritis
Conditions
Keywords
Osteoarthritis, Obesity, Liraglutide 3 mg, Liraglutide, Biomarkers
Brief summary
This is a substudy to a randomized 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 they will be randomized 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 biomarkers in obese patients with knee osteoarthritis following a randomization to Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.
Interventions
Sponsors
Henrik Gudbergsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 0 to 52 | Blood sampling |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in collagen II degradation fragment β-C2M | Week 0 to 52 | Blood sampling |
| Change in non-coding RNA type snoRNAs U38 and U48 | Week 0 to 52 | Blood sampling |
| Change in miRNA-454 | Week 0 to 52 | Blood sampling |
| Change in miRNA let-7e | Week 0 to 52 | Blood sampling |
| Change in Nesfatin-1 | Week 0 to 52 | Blood sampling |
Countries
Denmark
Outcome results
None listed