Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis; Weight Loss

NCT02928471 | Completed DMC

• 1 other identifier: 137.03
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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). In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counseling, after which. Patients 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. This substudy aims to investigate any changes in MRI associated with the initial 8-week weight loss intervention, and the value of CT scans in predicting the effect of weight loss.

Conditions

Osteoarthritis; Obesity

Keywords

Liraglutide; Liraglutide 3 mg; Osteoarthritis; Obesity; Magnetic resonance imaging; Computed tomography; Dynamic contrast enhanced MRI

Outcome Measures

Primary Outcomes (1)

• Change in the degree of inflammation in the knee-joint (DCE-MRI)

  Change will be assessed via a dynamic contrast enhanced MRI evaluation of corpus hoffa (Ballegaard C et al. and Riis RG et al.)

  Week -8 to 0

Secondary Outcomes (5)

• Change in the degree of inflammation in the knee-joint (CE-MRI)

  Week -8 to 0

• Change in the degree of inflammation in the knee-joint (MRI)

  Week -8 to 0

• Change in cartilage composition

  Week -8 to 0

• Change in bone marrow lesions (BML)

  Week -8 to 0

• Prediction of clinical symptoms (KOOS pain) by the level of crystal deposition on dual-energy CT at week 0

  Week 0

Study Arms (1)

Intensive dietary intervention

Supervised dietary weight loss program lasting 8 weeks.

Dietary Supplement: Intensive dietary intervention

Interventions

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.

Intensive dietary intervention

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants eligible for parent trial (NCT02905864), i.e. overweight/obese individuals with knee osteoarthritis

You may qualify if:

• Same as parent trial (NCT02905864)

You may not qualify if:

• Same as parent trial (NCT02905864)

Sponsors & Collaborators

• Henrik Gudbergsen: lead

Study Sites (1)

The Parker Institute and Department of Radiology at Bispebjerg and Frederiksberg Hospital

Frederiksberg, Capital Region, 2000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis; Obesity

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 10, 2016
• Study Start: November 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 25, 2019

Record last verified: 2019-03

Locations

DK (1)