Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Loss

NCT02931344 — Not applicable, Unknown, 200 participants, Henrik Gudbergsen

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

Registry	NCT02931344, acronym BIO-LOSEIT-I
Status	Unknown
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	200 (Estimated)
Sponsor	Henrik Gudbergsen (Other)
Conditions	Osteoarthrtis, Obesity
Interventions	Dietary Supplement: Dietary Supplement: Intensive dietary intervention (Dietary supplement)
Dates	start 2016-11-01, primary completion 2019-01-01 (estimated), completion 2019-06-01 (estimated), first posted 2016-10-13, last updated 2018-04-23
Locations	1 site in Denmark

-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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Intensive dietary intervention	Experimental	Dietary Supplement: Dietary Supplement: Dietary Supplement: Intensive dietary intervention	Supervised dietary weight loss program lasting 8 weeks

Dietary Supplement: Dietary Supplement: 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.

+Outcome measures

Primary outcomes

Change in collagen II degradation fragment α-C2M [Week -8 to 0]: Blood sampling

Secondary outcomes

Change in collagen II degradation fragment β-C2M [Week -8 to 0]: Blood sampling
Change in non-coding RNA type snoRNAs U38 and U48 [Week -8 to 0]: Blood sampling
Change in miRNA-454 [Week -8 to 0]: Blood sampling
Change in miRNA let-7e [Week -8 to 0]: Blood sampling
Change in Nesfatin-1 [Week -8 to 0]: Blood sampling

+Eligibility

Sex: All, ages: 18 Years to 74 Years

Inclusion Criteria:

* Same as parent trial (NCT02905864)

Exclusion Criteria:

* Same as parent trial (NCT02905864)

+Locations (1)

Facility	City	Country	Status
The Parker Institute	Frederiksberg, Capital Region	Denmark