Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Loss

NCT ID: NCT02931344

Last Updated: 2018-04-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-06-30

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.

Conditions

Osteoarthrtis; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intensive dietary intervention

Supervised dietary weight loss program lasting 8 weeks

Group Type: EXPERIMENTAL

Dietary Supplement: Dietary Supplement: Intensive dietary intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Same as parent trial (NCT02905864)

Exclusion Criteria

• Same as parent trial (NCT02905864)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henrik Gudbergsen

OTHER

Sponsor Role: lead

Responsible Party

Henrik Gudbergsen

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The Parker Institute

Frederiksberg, Capital Region, Denmark

Countries

Denmark

Other Identifiers

137.04

Identifier Type: -

Identifier Source: org_study_id