Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Loss

Not Applicable

• Conditions: Osteoarthrtis; Obesity

• Registration Number: NCT02931344
• Lead Sponsor: Henrik Gudbergsen

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.

Study Timeline

• Study First Submitted: 2016-09-23
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-13
• Study Start: 2016-11
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-19
• Last Update Posted: 2018-04-23
• Primary Completion: 2019-01
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Same as parent trial (NCT02905864)

Exclusion Criteria

• Same as parent trial (NCT02905864)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in collagen II degradation fragment α-C2M	Week -8 to 0	Blood sampling

Secondary Outcome Measures

Name	Time	Method
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
Change in collagen II degradation fragment β-C2M	Week -8 to 0	Blood sampling

Trial Locations

Locations (1)

The Parker Institute; 🇩🇰 Frederiksberg, Capital Region, Denmark