Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Maintenance

Obesity Clinical Trial

— BIO-LOSEIT-II  

Official title:

Biomarkers in Obese Patients With Knee Osteoarthritis Following Long-term Weight Maintenance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02928614
• Other study ID #: 137.08
• Status: Completed
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: Parker Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• Same as parent trial (NCT02905864)

Exclusion Criteria:

• Same as parent trial (NCT02905864)

Related Conditions & MeSH terms

• Obesity
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Liraglutide 3 mg (Saxenda)

• Liraglutide 3 mg placebo

Locations

Country	Name	City	State
Denmark	The Parker Institute	Frederiksberg	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Henrik Gudbergsen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in collagen II degradation fragment a-C2M	Blood sampling	Week 0 to 52
Secondary	Change in collagen II degradation fragment ß-C2M	Blood sampling	Week 0 to 52
Secondary	Change in non-coding RNA type snoRNAs U38 and U48	Blood sampling	Week 0 to 52
Secondary	Change in miRNA-454	Blood sampling	Week 0 to 52
Secondary	Change in miRNA let-7e	Blood sampling	Week 0 to 52
Secondary	Change in Nesfatin-1	Blood sampling	Week 0 to 52