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Completed

NCT Number: NCT02928614

Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Maintenance

This is a substudy to a randomized trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counseling, after which they will be randomized 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.

This substudy aims to investigate the impact of, and subsequent change of biomarkers in obese patients with knee osteoarthritis following a randomization to Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.

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Key information

Conditions

Osteoarthritis Arthritis Body Weight Joint Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Parker Institute

Frederiksberg, Capital Region, 2000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Same as parent trial (NCT02905864)

Exclusion criteria

  • Same as parent trial (NCT02905864)

Treatment and study plan

Liraglutide 3 mg (Saxenda)

Drug

Liraglutide 3 mg placebo

Drug

Primary outcomes

  1. Change in collagen II degradation fragment α-C2M

    Time frame: Week 0 to 52

    Blood sampling

Secondary outcomes

  1. Change in collagen II degradation fragment β-C2M

    Time frame: Week 0 to 52

    Blood sampling

  2. Change in non-coding RNA type snoRNAs U38 and U48

    Time frame: Week 0 to 52

    Blood sampling

  3. Change in miRNA-454

    Time frame: Week 0 to 52

    Blood sampling

  4. Change in miRNA let-7e

    Time frame: Week 0 to 52

    Blood sampling

  5. Change in Nesfatin-1

    Time frame: Week 0 to 52

    Blood sampling

Sponsors and collaborators

Lead sponsor

Henrik Gudbergsen

Other

Registry information

Official study title

Biomarkers in Obese Patients With Knee Osteoarthritis Following Long-term Weight Maintenance

Acronym: BIO-LOSEIT-II

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 10, 2016
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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