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

Primary Purpose

Osteoarthrtis, Obesity

Status

Unknown status

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Dietary Supplement: Dietary Supplement: Intensive dietary intervention

About this trial

This is an interventional treatment trial for Osteoarthrtis focused on measuring Osteoarthrtis, Obesity, Liraglutide 3 mg, Liraglutide, Biomarkers

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Same as parent trial (NCT02905864)

Exclusion Criteria:

Same as parent trial (NCT02905864)

Sites / Locations

The Parker Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intensive dietary intervention

Arm Description

Supervised dietary weight loss program lasting 8 weeks

Outcomes

Primary Outcome Measures

Change in collagen II degradation fragment α-C2M

Blood sampling

Secondary Outcome Measures

Change in collagen II degradation fragment β-C2M

Blood sampling

Change in non-coding RNA type snoRNAs U38 and U48

Blood sampling

Change in miRNA-454

Blood sampling

Change in miRNA let-7e

Blood sampling

Change in Nesfatin-1

Blood sampling

Full Information

NCT ID

NCT02931344

First Posted

September 23, 2016

Last Updated

April 19, 2018

Sponsor

Henrik Gudbergsen

1. Study Identification

Unique Protocol Identification Number

NCT02931344

Brief Title

Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Loss

Acronym

BIO-LOSEIT-I

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

January 2019 (Anticipated)

Study Completion Date

June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Henrik Gudbergsen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthrtis, Obesity

Keywords

Osteoarthrtis, Obesity, Liraglutide 3 mg, Liraglutide, Biomarkers

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intensive dietary intervention

Arm Type

Experimental

Arm Description

Supervised dietary weight loss program lasting 8 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Dietary Supplement: Dietary Supplement: Intensive dietary intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in collagen II degradation fragment α-C2M

Description

Blood sampling

Time Frame

Week -8 to 0

Secondary Outcome Measure Information:

Title

Change in collagen II degradation fragment β-C2M

Description

Blood sampling

Time Frame

Week -8 to 0

Title

Change in non-coding RNA type snoRNAs U38 and U48

Description

Blood sampling

Time Frame

Week -8 to 0

Title

Change in miRNA-454

Description

Blood sampling

Time Frame

Week -8 to 0

Title

Change in miRNA let-7e

Description

Blood sampling

Time Frame

Week -8 to 0

Title

Change in Nesfatin-1

Description

Blood sampling

Time Frame

Week -8 to 0

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Same as parent trial (NCT02905864) Exclusion Criteria: Same as parent trial (NCT02905864)

Facility Information:

Facility Name

The Parker Institute

City

Frederiksberg

State/Province

Capital Region

ZIP/Postal Code

2000

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Loss

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