RECRUITING

Role of Insulin Action in Psoriasis Pathogenesis

Conditions

Psoriasis Plaque Psoriasis Insulin Resistance PreDiabetes Overweight and Obesity Insulin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Role of Insulin Action in Psoriasis Pathogenesis

Quick Facts

Study Start:2024-02-02

Study Completion:2025-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06242847

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Zachary Sone

CONTACT

2123059336

zds2120@cumc.columbia.edu

Principal Investigator

Joshua R Cook, MD, PhD

PRINCIPAL_INVESTIGATOR

Columbia University

Study Locations (Sites)

Columbia University Irving Medical Center

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Columbia University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-02

Study Completion Date2025-05

Study Record Updates

Study Start Date2024-02-02

Study Completion Date2025-05

Terms related to this study

Keywords Provided by Researchers

Insulin
Insulin resistance
Psoriasis

Additional Relevant MeSH Terms

Psoriasis
Plaque Psoriasis
Insulin Resistance
PreDiabetes
Overweight and Obesity