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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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:
. Clinical concern for absolute insulin deficiency (e.g., type 1 diabetes, pancreatic disease)
. Reproductive concerns
. Known, documented history, at the time of screening, of any of the following medical conditions:
. Use of medications associated methemoglobinemia within 48 hours of shave biopsy procedures: