Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Loss

Obesity Clinical Trial

— BIO-LOSEIT-I  

Official title:

Biomarkers in Obese Patients With Knee Osteoarthritis Following a Significant Weight Loss

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02931344
• Other study ID #: 137.04
• Status: Active, not recruiting
• Phase: N/A
• First received: September 23, 2016
• Last updated: April 19, 2018
• Start date: November 2016
• Est. completion date: June 2019

Study information

• Verified date: April 2018
• Source: Parker Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• Same as parent trial (NCT02905864)

Exclusion Criteria:

• Same as parent trial (NCT02905864)

Related Conditions & MeSH terms

• Obesity
• Osteoarthritis
• Osteoarthritis, Knee
• Osteoarthrtis
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
Denmark	The Parker Institute	Frederiksberg	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Henrik Gudbergsen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in collagen II degradation fragment a-C2M	Blood sampling	Week -8 to 0
Secondary	Change in collagen II degradation fragment ß-C2M	Blood sampling	Week -8 to 0
Secondary	Change in non-coding RNA type snoRNAs U38 and U48	Blood sampling	Week -8 to 0
Secondary	Change in miRNA-454	Blood sampling	Week -8 to 0
Secondary	Change in miRNA let-7e	Blood sampling	Week -8 to 0
Secondary	Change in Nesfatin-1	Blood sampling	Week -8 to 0