Role of Insulin Action in Psoriasis Pathogenesis

Description

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.

Conditions

Psoriasis, Plaque Psoriasis, Insulin Resistance, PreDiabetes, Overweight and Obesity

Study Overview

Study Details

Study overview

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.

Role of Insulin Action in Psoriasis Pathogenesis

Role of Insulin Action in Psoriasis Pathogenesis

Condition
Psoriasis
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Body mass index of 25.0-40.0 kg/m2
  • 2. Able to understand written and spoken English and/or Spanish
  • 3. 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.
  • 4. Diagnosed with plaque psoriasis, documented using Psoriasis Area and Severity Index (PASI)
  • 5. 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
  • * For Insulin Intermediate (II) group:
  • * Hemoglobin A1c \< 6.5%, and
  • * Fasting plasma glucose 80-125 mg/dL, and
  • * Fasting plasma insulin 10-14 μIU/mL
  • * For Insulin Resistant (IR) group:
  • * Hemoglobin A1c \< 6.5%, and
  • * Fasting plasma glucose 80-125 mg/dL, and
  • * Fasting plasma insulin ≥ 15 μIU/mL
  • 1. Inability to provide informed consent in English or Spanish
  • 2. Concerns arising at screening visit (any of the following):
  • 3. Laboratory evidence of diabetes mellitus, either determined during the study or based on previous documentation:
  • * Hemoglobin A1c ≥ 6.5%, and/or
  • * Fasting plasma glucose ≥ 126 mg/dL
  • * Plasma glucose ≥ 200 mg/dL at 2 hours after ingestion of a 75-g oral glucose load
  • * Random plasma glucose ≥ 200 mg/dL associated with typical hyperglycemic symptoms, diabetic ketoacidosis, or hyperglycemic-hyperosmolar state
  • 4. History of gestational diabetes mellitus
  • 5. 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:
  • 6. Clinical concern for absolute insulin deficiency (e.g., type 1 diabetes, pancreatic disease)
  • 7. Reproductive concerns
  • * Surgical sterilization (e.g., bilateral tubal occlusion, bilateral oophorectomy and/or salpingectomy, hysterectomy)
  • * Combined oral contraceptive pills taken daily, including during the study
  • * Intrauterine device (levonorgestrel-eluting or copper) active at the time of the study
  • * Medroxyprogesterone acetate (Depo-Provera®) injection active at the time of the study
  • * Etonogestrel implants (e.g., Implanon®, etc.) active at the time of the study
  • * Norelgestromin/ethinyl estradiol transdermal system (e.g., Ortho-Evra®) active at the time of the study
  • 8. Known, documented history, at the time of screening, of any of the following medical conditions:
  • 9. Use of medications associated methemoglobinemia within 48 hours of shave biopsy procedures:
  • 10. History of severe infection or ongoing febrile illness within 30 days of screening
  • 11. Any other disease, condition, or laboratory value that, in the opinion of the investigator, would place the participant at an unacceptable risk and/or interfere with the analysis of study data.
  • 12. Known allergy/hypersensitivity to any component of the medicinal product formulations (including amide anesthetics), IV infusion equipment, plastics, adhesive or silicone, history of infusion site reactions with IV administration of other medicines, or ongoing clinically important allergy/hypersensitivity as judged by the investigator.
  • 13. Concurrent enrollment in another clinical study of any investigational drug therapy within 6 months prior to screening or within 5 half-lives of an investigational agent, whichever is longer.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Columbia University,

Joshua R Cook, MD, PhD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

2025-05