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

April 19, 2018 updated by: Henrik Gudbergsen

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital Region
      • Frederiksberg, Capital Region, Denmark, 2000
        • The Parker Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Same as parent trial (NCT02905864)

Exclusion Criteria:

  • Same as parent trial (NCT02905864)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive dietary intervention
Supervised dietary weight loss program lasting 8 weeks
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in collagen II degradation fragment α-C2M
Time Frame: Week -8 to 0
Blood sampling
Week -8 to 0

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henrik Gudbergsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

April 23, 2018

Last Update Submitted That Met QC Criteria

April 19, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 137.04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Dietary Supplement: Dietary Supplement: Intensive dietary intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe