Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Loss
NCT02931344 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2018-04-23
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
Conditions
- Osteoarthrtis
- Obesity
Interventions
- 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.
Sponsors & Collaborators
-
Henrik Gudbergsen
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 74 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-11-30
- Primary Completion
- 2019-01-31
- Completion
- 2019-06-30
Countries
- Denmark
Study Locations
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