GLP-1 Analogs or Nutrition Counseling for Psoriatic Arthritis
This study is looking at how well GLP-1 agonists (medications like Ozempic or Wegovy, often used for type 2 diabetes and weight management) or nutrition counseling can help people with Psoriatic Arthritis (PsA). PsA is a condition that causes joint pain and can affect other parts of your body. We want to see if these treatments improve PsA symptoms in adults who also have obesity and type 2 diabetes. The study will compare the effects of GLP-1 agonists versus nutrition counseling on your PsA symptoms over 12 and 24 weeks. We are looking for about 22 adults, aged 18 and older, who have been diagnosed with PsA and have a Body Mass Index (BMI) of 30 or higher.
- Study design
- This is a pragmatic randomized controlled trial, meaning participants will be randomly assigned to receive either GLP-1 agonists or nutrition counseling. The study plans to enroll 22 participants.
- What's involved
- The study measures changes in your disease activity at Week 12 and Week 24. This suggests you would participate in the study for at least 24 weeks, with assessments at these time points.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your disease outcomes will be measured at Week 12 and Week 24, indicating a follow-up period of at least 24 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Inclusion
Exclusion
What this trial measures
- Change from the baseline Minimal Disease Activity (MDA) Scores at Week 12 and 24 with GLP-1 Agonists vs Nutrition CounselingWeek 12 and 24
In order to meet Minimal Disease Activity (MDA) participants need to meet 5 of the 7 criteria: tender joint count less than or equal to 68 and greater than or equal to 1 (TJC68), swollen joint count less than or equal to 66 and greater than or equal to 1 (SJC66), psoriasis body surface area is less than or equal to 3%, patient pain Visual Analogue Scale (VAS) is less than or equal to 15mm, patient global disease activity VAS is less than or equal to 20mm, Health Assessment Questionnaire (HAQ) is less than or equal to 0.5 and tender entheseal points is less than or equal to 1. One of the outcomes of this study is to see how these scores change with the participants receiving a GLP-1 or nutrition counseling.
- Proportion of Patients who Achieve Disease Activity in Psoriatic Arthritis (DAPSA) Remission with GLP-1 Agonists Vs. Nutrition Counseling at Week 12 and 24Week 12 and 24
DASPA is a composite measure based on the summation of four variables: tender and swollen joints (TJC68, SJC66), C-reactive protein (CRP), Patient Global Assessment (PtGA) and Patient Pain both reported on a 0-100 mm VAS. DASPA classifications validated for PsA include Less than or equal to 4 (remission), greater than 4 but less than or equal to 14 is low disease activity. Greater than 14 but less than or equal to 28 is moderate disease activity and greater than 28 is high disease activity.