Ultrasound of the Knee in Obese Patients With Knee Osteoarthritis; Weight Loss

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02931370
• Date of registration: 07/10/2016
• Prospective Registration: Yes
• Primary sponsor: Henrik Gudbergsen
• Public title: Ultrasound of the Knee in Obese Patients With Knee Osteoarthritis; Weight Loss US-LOSEIT-I
• Scientific title: Ultrasound of the Knee in Obese Patients With Knee Osteoarthritis Following a Significant Weight Loss, Investigating the Impact on Inflammation
• Date of first enrolment: November 2016
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02931370
• Study type: Observational

Countries of recruitment

Denmark

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 74 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obesity

Osteoarthritis

Intervention(s)

Dietary Supplement: Dietary Supplement: Intensive dietary intervention

Primary Outcome(s)

Change in the degree of inflammation in the knee-joint (Greyscale-score) [Time Frame: Week -8 to 0]

Secondary Outcome(s)

Change in knee-joint effusion [Time Frame: Week -8 to 0]

Change in the degree of inflammation in the knee-joint (Doppler-score) [Time Frame: Week -8 to 0]

Change in the degree of inflammation in the knee-joint (Greyscale-size) [Time Frame: Week -8 to 0]

Secondary ID(s)

137.06

Source(s) of Monetary Support

Please refer to primary and secondary sponsors