Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Loss (BIO-LOSEIT-I)

Henrik Gudbergsen

Status: Unknown

Conditions: Osteoarthrtis; Obesity

Treatments: Dietary Supplement: Dietary Supplement: Dietary Supplement: Intensive dietary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02931344

137.04

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).

This substudy aims to investigate any changes in biomarkers associated with the initial 8-week weight loss intervention

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Same as parent trial (NCT02905864)

Exclusion criteria

• Same as parent trial (NCT02905864)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Intensive dietary intervention

Experimental group

Description:

Supervised dietary weight loss program lasting 8 weeks

Treatment:

Dietary Supplement: Dietary Supplement: Dietary Supplement: Intensive dietary intervention