Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Henrik Gudbergsen
Age
18–74
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
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
