NCT02931344

Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Loss

Biomarkers in Obese Patients With Knee Osteoarthritis Following a Significant Weight Loss

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Henrik Gudbergsen · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthrtis
• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary Supplement: Dietary Supplement: Intensive dietary intervention	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.

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-01-01
• Completion: 2019-06-01
• First posted: 2016-10-13
• Last updated: 2018-04-23

Locations

1 site across 1 country: Denmark