Role of Insulin Action in Psoriasis Pathogenesis

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• 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):

‣ For Insulin Sensitive (IS) group:

‣ • Hemoglobin A1c \< 5.7%, and

∙ Fasting plasma glucose \< 95 mg/dL, and

∙ Fasting plasma insulin \< 10 μIU/mL, and

∙ 2-hour post-challenge glucose \< 140 mg/dL

⁃ For Insulin Intermediate (II) group:

‣ • Hemoglobin A1c \< 6.5%, and

‣ • Fasting plasma glucose 80-125 mg/dL, and

‣ • Fasting plasma insulin \< 15 μIU/mL, and

‣ • 2-hour post-challenge glucose \< 200 mg/dL, and

‣ • Not otherwise meeting all criteria for the IS group

⁃ For Insulin Resistant (IR) group:

• Hemoglobin A1c \< 6.5%, and

∙ Fasting plasma glucose 80-125 mg/dL, and

∙ Fasting plasma insulin ≥ 15 μIU/mL, and

∙ 2-hour post-challenge glucose \< 200 mg/dL

⁃ NOTE: Group assignments will be made retroactively, after observational data has been collected. Those not fitting into any of these groups will have their data excluded from further analysis.

Locations
United States
New York
Columbia University Irving Medical Center
RECRUITING
New York
Contact Information
Primary
Joshua R Cook, MD, PhD
jrc2175@cumc.columbia.edu
212 305 2663
Time Frame
Start Date: 2024-02-02
Estimated Completion Date: 2027-05
Participants
Target number of participants: 18
Treatments
Insulin Sensitive (IS) with psoriasis
Patients with plaque psoriasis found to have:~* Hemoglobin A1c \< 5.7%~* Fasting plasma glucose: \< 95 mg/dL~* Fasting serum insulin: \< 10 micro-international units per milliliter (μIU/mL)~* 2-hour post-challenge glucose \< 140 mg/dL~NOTE: Group assignments made retroactively based on the observational study results.
Insulin Intermediate (II) with psoriasis
Patients with plaque psoriasis found to have:~* Hemoglobin A1c \< 6.5%~* Fasting plasma glucose \<125 mg/dL~* Fasting serum insulin: \<15 μIU/mL~* 2-hour post-challenge glucose \< 200 mg/dL~NOTE: Group assignments made retroactively based on the observational study results.~• Not otherwise meeting all criteria for inclusion in the IS group
Insulin Resistant (IR) with psoriasis
Patients with plaque psoriasis found to have:~* Fasting serum/plasma insulin ≥ 15 μIU/mL~* Fasting plasma glucose 80-125 mg/dL and~* Hemoglobin A1c \< 6.5% and~* 2-hour post-challenge glucose \< 200 mg/dL~NOTE: Group assignments made retroactively based on the observational study results.
Related Therapeutic Areas
Sponsors
Leads: Columbia University

This content was sourced from clinicaltrials.gov