Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Loss

NCT02931344 · Unknown status

Last updated 2026-05-28

This clinical trial is studying how weight loss affects certain biomarkers in people with both knee osteoarthritis and obesity.

Status Unknown status The sponsor has not confirmed the status recently.

Phase Not applicable Not a phased drug trial (e.g. a device or behavioral study).

Type Interventional (clinical trial)

Design open-label (no blinding) treatment study

Participants 200 people Planned (estimated).

Who can join Ages 18–74 · all sexes

Timeline Started 2016-11 · est. completion 2019-06

Where 1 site · Denmark

What this study is testing ClinicalTrials.gov NCT02931344 ↗

Description as written by the study sponsor.

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

Treatments tested

Dietary Supplement: Dietary Supplement: Intensive dietary intervention Dietary supplement

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.

Main thing measured	Change in collagen II degradation fragment α-C2M
Sponsor	Henrik Gudbergsen
Conditions studied	Osteoarthrtis, Obesity
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02931344 ↗