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Ultrasound of the Knee in Obese Patients With Knee Osteoarthritis; Weight Loss (US-LOSEIT-I)

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ClinicalTrials.gov Identifier: NCT02931370
Recruitment Status : Completed
First Posted : October 13, 2016
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Henrik Gudbergsen, Parker Research Institute

Tracking Information
First Submitted Date October 7, 2016
First Posted Date October 13, 2016
Last Update Posted Date March 25, 2019
Study Start Date November 2016
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 10, 2016)
Change in the degree of inflammation in the knee-joint (Greyscale-score) [ Time Frame: Week -8 to 0 ]
Change will be assessed by grey-scale ultrasound in the suprapatellar, the medial, and the lateral recess´ (sum-score (0-9), derived from these three positions)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02931370 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 10, 2016)
  • Change in knee-joint effusion [ Time Frame: Week -8 to 0 ]
    Change in effusion will be assessed via the US knee OA MUS score (Riecke BF et al.)
  • Change in the degree of inflammation in the knee-joint (Greyscale-size) [ Time Frame: Week -8 to 0 ]
    Change will be assessed by grey-scale ultrasound in the suprapatellar, the medial, and the lateral recess´ (sum of size-scores (mm) of these three positions)
  • Change in the degree of inflammation in the knee-joint (Doppler-score) [ Time Frame: Week -8 to 0 ]
    Change will be assessed by Doppler ultrasound in the suprapatellar, the medial, and the lateral recess´ (sum-score (0-9), derived from these three positions)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ultrasound of the Knee in Obese Patients With Knee Osteoarthritis; Weight Loss
Official Title Ultrasound of the Knee in Obese Patients With Knee Osteoarthritis Following a Significant Weight Loss, Investigating the Impact on Inflammation
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). 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 patients 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.

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

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants eligible for parent trial (NCT02905864), i.e. overweight/obese individuals with knee osteoarthritis
Condition
  • Osteoarthritis
  • Obesity
Intervention 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.
Study Groups/Cohorts Intensive dietary intervention
Supervised dietary weight loss program lasting 8 weeks
Intervention: Dietary Supplement: Dietary Supplement: Intensive dietary intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: October 10, 2016)
200
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2019
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Informed consent obtained
  • Clinical diagnosis of knee OA (American College of Rheumatology (ACR) criteria) confirmed by radiology but restricted to definite radiographic OA at early to moderate-stages (Kellgren-Lawrence grades 1, 2, or 3)
  • Age ≥ 18 years and < 75 years
  • Body mass index (BMI) ≥ 27 kg/m2
  • Stable body weight during the previous 3 months (< 5 kg self-reported weight change)
  • Motivated for weight loss

Exclusion Criteria:

  • On-going participation, or participation within the last 3 months, in an organised weight loss programme (or within the last 3 months)
  • Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial
  • Current use or use within three months before this trial of GLP-1 receptor agonist, pramlintide, sibutramine, orlistat, zonisamide, topiramate, or phentermine
  • Type 1 diabetes
  • Type 2 diabetes treated with glucose-lowering drugs other than metformin
  • Alloplasty in target knee joint (see section 6.3)
  • End stage disease in target knee joint (Kellgren-Lawrence grade 4)
  • Immuno-inflammatory disease
  • Chronic wide-spread pain
  • Pregnancy or insufficient anti-conception therapy for female fertile patients
  • Breast-feeding
  • Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x above upper normal range (UNR)
  • Surgery scheduled for the trial duration period, except for minor surgical procedures
  • Surgical procedures such as arthroscopy or injections into a knee within 3 months prior to enrolment
  • Previous surgical treatment for obesity (excluding liposuction >1 year before trial entry)
  • Thyroid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L
  • Obesity secondary to endocrinologic or eating disorders or to treatment with medicinal products that may cause weight gain
  • Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
  • Inflammatory bowel disease
  • Congestive heart failure, New York Heart Association (NYHA) class III-IV
  • Diabetic gastroparesis
  • History of or current diagnosis of pancreatitis (acute and/or chronic) or pancreatic cancer
  • History of cancer with the exception of in-situ malignancies of the skin or cervix uteri
  • History of major depressive disorder, a PHQ-9 (Patient Health Questionnaire-9) score of more than 15, or a history of other severe psychiatric disorders or diagnosis of an eating disorder
  • Subjects with a lifetime history of a suicide attempt or history of any suicidal behaviour within the past month before entry into the trial
  • Inability to speak Danish fluently
  • A mental state impeding compliance with the program
  • Use of opioids or similar strong analgesics
  • Allergic reactions to the active ingredients of Saxenda, such as hypotension, palpitations, dyspnoea and oedema
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02931370
Other Study ID Numbers 137.06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Henrik Gudbergsen, Parker Research Institute
Study Sponsor Henrik Gudbergsen
Collaborators Not Provided
Investigators Not Provided
PRS Account Parker Research Institute
Verification Date March 2019