Role of Insulin Action in Psoriasis Pathogenesis (NCT06242847) | Clinical Trial Compass
TerminatedNot Applicable
Role of Insulin Action in Psoriasis Pathogenesis
Stopped: The study's collaborating dermatologist left the institution, and so skin biopsies could no longer be performed.
United States10 participantsStarted 2024-02-02
Plain-language summary
The goal of this study is to collect more information from people with plaque psoriasis and to determine if insulin plays a role in the pathogenesis of psoriasis. The main question it aims to answer is if insulin action is preserved or even enhanced in psoriatic lesions despite insulin resistance elsewhere. Participants with plaque psoriasis will have punch biopsies taken of lesional and non-lesional skin after an overnight fast and then during an oral glucose tolerance test. Biopsy specimens will then be assessed for markers of insulin action.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Body mass index of 25.0-40.0 kg/m2
✓. Able to understand written and spoken English and/or Spanish
✓. Written informed consent (in English or Spanish) and any locally required authorization (e.g., Health Insurance Portability and Accountability Act) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations.
✓. Diagnosed with plaque psoriasis, documented using Psoriasis Area and Severity Index (PASI)
✓. Glucose metabolism status as follows (determined only retrospectively based on data collected during the study):
Exclusion criteria
✕. Inability to provide informed consent in English or Spanish
✕. Laboratory evidence of diabetes mellitus, either determined during the study or based on previous documentation:
✕. History of gestational diabetes mellitus
✕. Use of antidiabetic medications within the 90 days prior to screening, including those prescribed for other indications (e.g., weight control, restoration of ovulation in of polycystic ovarian syndrome), including:
What they're measuring
1
Skin insulin sensitivity: ratio of phosphorylated to total AKT in skin biopsies
Timeframe: Up to 120 minutes from the start of OGTT