About this trial
Background Psoriatic arthritis (PsA) patients are at increased risk of cardiovascular disease. Glucagon-Like Peptide-1 (GLP-1) receptor agonists are cardiovascular protective in diabetics. They have also anti-inflammatory properties. It is hypothesized GLP-1 receptor agonists can prevent the progression of atherosclerosis due to the combination of metabolic factors and disease activity control in non-diabetic PsA patients.
Objectives To investigate the vascular effects of GLP-1 receptor agonists in PsA patients without diabetes. Their metabolic and anti-inflammatory roles will also be examined.
Design and subjects This is a pilot randomized open-labelled trial. We plan to enroll 40 non-diabetic patients with PsA. Participants will be randomized 1:1 to either GLP-1 receptor agonist (semaglutide) or control group.
Study instruments Subclinical carotid artherosclerosis is assessed by high-resolution ultrasound. Arterial stiffness is measured using pulse wave velocity by a tonometry system, and augmentation index by the SphygmoCor device. These assessments will be done at baseline and 24 weeks. Drug adversities will also be documented. Anthropometric measurements, sugar metabolism and lipid levels as well as the PsA disease activity will be monitored.
Eligibility criteria
Qualifiers
fulfill the ClASsification criteria for Psoriatic Arthritis,
are rheumatoid factor negative,
BMI >=25 kg/m2,
are over 18 years old and
Disqualifiers
have prior therapy with GLP-1 receptor agonists during the last 24 weeks,
have pre-existing diabetes,
have liver or renal impairment,
have known or symptoms suggestive of CVD,
Trial design
Treatments tested in this trial
- Semaglutide 0.5 mg
- Semaglutide 1.0 mg
- Semaglutide 0.25 mg
- No intervention