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Use of Total-Body PET to Quantify Systemic and Cutaneous Inflammation in Psoriasis Patients Before and After Intervention With a Nutritionally Balanced Diet

RecruitingNAAges 18 Years - anyAllUniversity of California, Davis
NCT06574178 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Psoriasis is a chronic inflammatory disease that affects the skin and joints in 2-3 % of people in the United States. This inflammation of the skin, joints, and blood vessels in patients with psoriasis has been measured by older PET Scan technology but with limitations. With the new EXPLORER PET scanner technology, the investigators are testing to see if the EXPLORER is better than previous PET scanners and improve our ability to assess inflammation in patients. Also, it is known that the typical Western Diet - high in saturated fats, added sugars, and low in fiber - contributes to obesity and inflammation worldwide. There is evidence in animals that these signs of inflammation are reversible within 4 weeks when changed to a more balanced diet. Thus, this study aims to assess whether there are detectable decreases in inflammation of the skin and body of psoriasis patients who usually ea

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults (\>18 year) * Both sexes * Must have a history of psoriasis of at least 3% body surface area affected by skin psoriasis (in a body area that the subject will allow the PI to perform several skin biopsies as noted below (optional)) and may carry a diagnosis of psoriatic arthritis as well * Patients will have a BMI of \>/=25 which is consistent with being overweight - Willing and able to fast for at least 6 hours before and for the duration of the scan visit * No strenuous exercise for 24 hours prior to being scanned * Recruited patients must habitually consume a WD-type diet that will be evaluated by using DHQ III food frequency questionnaire along with three-day food record14. Subsequently, the Healthy Eating Index will be calculated and participants with a poor dietary pattern (score below 58) will be eligible for the study15. Exclusion Criteria: * Those taking anti-diabetic oral or injected medications * Those already ingesting a caloric- or component-restricted diet * Vegan, vegetarian or food allergy or intolerance to the ingredients of the diet * \>5% change in body weight in the last 2 months * Those taking systemic medications for the purpose of treating psoriasis or psoriatic arthritis for at least 3 months prior to first PET scan or during the duration of the trial * Self-reported history of dysphoria or anxiety in closed spaces (claustrophobia) * Uncontrolled diabetes or blood glucose level greater than 180 mg/dl at the time of radiotracer injection * Body weight \>240 kg due to limitations of the scanner bed * Known inflammatory or other infectious disease that can confound assessment * Pregnant or breast-feeding (urine pregnancy test will be administered prior to start of each PET/CT session for all participants who are able to get pregnant between 18 to 60 years old, unless documented hysterectomy or bilateral ovarian removal is available, because of risks from ionizing radiation) * Inability to lie motionless on the scanner bed with the arms by the side for up to 60 minutes * Currently participating in another conflicting research study. Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only. * Unwilling to sign informed consent * Inability to understand the risks and benefits of the study * Prisoners
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What it tests

  • Dietary Counseling
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Where

1 site
University of California, Davis - Dermatology Department
Sacramento, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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