Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis; Weight Loss (IM-LOSEIT-I)

Henrik Gudbergsen

Status: Completed

Conditions: Osteoarthritis; Obesity

Treatments: Dietary Supplement: Intensive dietary intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02928471

137.03

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Same as parent trial (NCT02905864)

Further Exclusion Criteria

• Same as parent trial (NCT02905864)
• Usual exclusion criteria for MRI (i.e. pacemakers etc.)

Trial design

200 participants in 1 patient group

Intensive dietary intervention

Description:

Supervised dietary weight loss program lasting 8 weeks.

Treatment:

Dietary Supplement: Intensive dietary intervention