Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Maintenance

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02928614
• Date of registration: 07/10/2016
• Prospective Registration: Yes
• Primary sponsor: Henrik Gudbergsen
• Public title: Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Maintenance BIO-LOSEIT-II
• Scientific title: Biomarkers in Obese Patients With Knee Osteoarthritis Following Long-term Weight Maintenance
• Date of first enrolment: November 2016
• Target sample size: 150
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02928614
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Denmark

Key inclusion & exclusion criteria

Inclusion Criteria:

- Same as parent trial (NCT02905864)

Exclusion Criteria:

- Same as parent trial (NCT02905864)



Age minimum: 18 Years
Age maximum: 74 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obesity

Osteoarthritis

Intervention(s)

Drug: Liraglutide 3 mg placebo

Drug: Liraglutide 3 mg (Saxenda)

Primary Outcome(s)

Change in collagen II degradation fragment a-C2M [Time Frame: Week 0 to 52]

Secondary Outcome(s)

Change in Nesfatin-1 [Time Frame: Week 0 to 52]

Change in non-coding RNA type snoRNAs U38 and U48 [Time Frame: Week 0 to 52]

Change in miRNA-454 [Time Frame: Week 0 to 52]

Change in collagen II degradation fragment ß-C2M [Time Frame: Week 0 to 52]

Change in miRNA let-7e [Time Frame: Week 0 to 52]

Secondary ID(s)

137.08

Source(s) of Monetary Support

Please refer to primary and secondary sponsors