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Trial record 39 of 364 for:    Recruiting, Not yet recruiting, Available Studies | "weight loss"

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

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ClinicalTrials.gov Identifier: NCT02931344
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Henrik Gudbergsen, Parker Research Institute

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


Condition or disease Intervention/treatment Phase
Osteoarthrtis Obesity Dietary Supplement: Dietary Supplement: Dietary Supplement: Intensive dietary intervention Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biomarkers in Obese Patients With Knee Osteoarthritis Following a Significant Weight Loss
Study Start Date : November 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Change in collagen II degradation fragment α-C2M [ Time Frame: Week -8 to 0 ]
    Blood sampling


Secondary Outcome Measures :
  1. Change in collagen II degradation fragment β-C2M [ Time Frame: Week -8 to 0 ]
    Blood sampling

  2. Change in non-coding RNA type snoRNAs U38 and U48 [ Time Frame: Week -8 to 0 ]
    Blood sampling

  3. Change in miRNA-454 [ Time Frame: Week -8 to 0 ]
    Blood sampling

  4. Change in miRNA let-7e [ Time Frame: Week -8 to 0 ]
    Blood sampling

  5. Change in Nesfatin-1 [ Time Frame: Week -8 to 0 ]
    Blood sampling



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Same as parent trial (NCT02905864)

Exclusion Criteria:

  • Same as parent trial (NCT02905864)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931344


Locations
Denmark
The Parker Institute Recruiting
Frederiksberg, Capital Region, Denmark, 2000
Contact: Lars Erik Kristensen, MD, PhD    +45 38 16 41 55    lars.erik.kristensen@regionh.dk   
Contact: henrik r gudbergsen, MD, PhD    +45 29 84 28 88    henrik.rindel.gudbergsen.01@regionh.dk   
Sponsors and Collaborators
Henrik Gudbergsen

Responsible Party: Henrik Gudbergsen, MD, PhD, Parker Research Institute
ClinicalTrials.gov Identifier: NCT02931344     History of Changes
Other Study ID Numbers: 137.04
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Henrik Gudbergsen, Parker Research Institute:
Osteoarthrtis
Obesity
Liraglutide 3 mg
Liraglutide
Biomarkers

Additional relevant MeSH terms:
Osteoarthritis
Weight Loss
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists