- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06242847
Role of Insulin Action in Psoriasis Pathogenesis
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Zachary Sone
- Phone Number: 2123059336
- Email: zds2120@cumc.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Recruiting
- Columbia University Irving Medical Center
-
Principal Investigator:
- Joshua R Cook, MD, PhD
-
Contact:
- Zachary Sone
- Phone Number: 212-305-9336
- Email: zds2120@cumc.columbia.edu
-
Sub-Investigator:
- Nur Bedeir, MD
-
Sub-Investigator:
- Lindsey A Bordone, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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):
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
Exclusion Criteria:
- Inability to provide informed consent in English or Spanish
- Concerns arising at screening visit (any of the following):
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
- 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:
• Metformin, thiazolidinediones, sulfonylureas, meglitinides, dipeptidyl peptidase-4 (DPP4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, sodium/glucose cotransporter 2 (SGLT2) inhibitors, amylin mimetics, acarbose, insulin
- Clinical concern for absolute insulin deficiency (e.g., type 1 diabetes, pancreatic disease)
Reproductive concerns
i. Women of childbearing potential not using highly effective contraception, defined as:
- 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
ii. Women currently pregnant
iii. Women currently breastfeeding
Known, documented history, at the time of screening, of any of the following medical conditions:
i. Bleeding disorders, including due to anticoagulation or use of P2Y12 inhibitors ii. Anemia requiring treatment iii. Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Use of medications associated methemoglobinemia within 48 hours of shave biopsy procedures:
i. Nitrates/nitrites: nitric oxide, nitroglycerin, nitroprusside, nitrous oxide ii. Antineoplastics: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase iii. Antibiotics: dapsone, nitrofurantoin, paraaminosalicylic acid, sulfonamides iv. Antimalarials: chloroquine, primaquine v. Anticonvulsants: phenobarbital, phenytoin, valproic acid vi. Others: acetaminophen, metoclopramide, quinine, sulfasalazine
- History of severe infection or ongoing febrile illness within 30 days of screening
- 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.
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Insulin Sensitive (IS) with psoriasis
Patients with plaque psoriasis and overweight/obese (BMI 25-35) found to have:
|
Participants ingest 75 g of glucose in 10 fl oz aqueous solution (fruit flavored) after an overnight fast.
Blood is drawn at baseline (t = 0 min) and at 120 min after ingestion.
This test is non-experimental.
Punch biopsies are taken from lesional (psoriatic) and non-lesional skin after an overnight fast and at 120 min after ingestion of glucose during OGTT.
This procedure is non-experimental.
|
Insulin Intermediate (II) with psoriasis
Patients with plaque psoriasis and overweight/obese (BMI 25-35) found to have:
|
Participants ingest 75 g of glucose in 10 fl oz aqueous solution (fruit flavored) after an overnight fast.
Blood is drawn at baseline (t = 0 min) and at 120 min after ingestion.
This test is non-experimental.
Punch biopsies are taken from lesional (psoriatic) and non-lesional skin after an overnight fast and at 120 min after ingestion of glucose during OGTT.
This procedure is non-experimental.
|
Insulin Resistant (IR) with psoriasis
Patients with plaque psoriasis and overweight/obese (BMI 25-35) found to have:
|
Participants ingest 75 g of glucose in 10 fl oz aqueous solution (fruit flavored) after an overnight fast.
Blood is drawn at baseline (t = 0 min) and at 120 min after ingestion.
This test is non-experimental.
Punch biopsies are taken from lesional (psoriatic) and non-lesional skin after an overnight fast and at 120 min after ingestion of glucose during OGTT.
This procedure is non-experimental.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin insulin sensitivity: ratio of phosphorylated to total AKT in skin biopsies
Time Frame: Up to 120 minutes from the start of OGTT
|
Investigators will perform Western blots on skin biopsies using antibodies to phosphorylated (T308, S473) and total AKT.
The ratio of phosphorylated to total AKT will be determined using densitometry of Western blots and/or by enzyme-linked immunosorbent assays (ELISA), each measured in arbitrary units (AU).
|
Up to 120 minutes from the start of OGTT
|
Fasting plasma glucose level
Time Frame: Before OGTT (baseline = 0 minutes), During OGTT (up to 120 minutes from start of OGTT)
|
Plasma glucose (units: mg/dL) after an overnight fast (> 8 hours).
A blood test will be done.
A healthy (normal) fasting blood glucose level for someone without diabetes is 70 to 99 mg/dL.
|
Before OGTT (baseline = 0 minutes), During OGTT (up to 120 minutes from start of OGTT)
|
Fasting serum insulin level
Time Frame: Before OGTT (baseline = 0 minutes), During OGTT (up to 120 minutes from start of OGTT)
|
Serum insulin (units: μIU/mL) after an overnight fast (> 8 hours).
A blood test will be done.
The normal range of fasting insulin varies somewhat between labs, but around 2 to 20 mIU/mL is considered normal by most.
|
Before OGTT (baseline = 0 minutes), During OGTT (up to 120 minutes from start of OGTT)
|
Fasting serum C-peptide level
Time Frame: Before OGTT (baseline = 0 minutes), During OGTT (up to 120 minutes from start of OGTT)
|
Serum C-peptide (units: ng/mL) after an overnight fast (> 8 hours).
A blood test will be done.
A normal result of a C-peptide test ranges from 0.5 ng/mL to 2.0 ng/mL (or 0.17 to 0.83 nmol/L).
|
Before OGTT (baseline = 0 minutes), During OGTT (up to 120 minutes from start of OGTT)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum triglyceride (TG) level during OGTT
Time Frame: During OGTT (up to 120 minutes from start of OGTT)
|
Measurement of serum triglyceride level (units: mg/dL) during OGTT.
A blood test will be done.
|
During OGTT (up to 120 minutes from start of OGTT)
|
Serum free fatty acid (FFA) levels during OGTT
Time Frame: During OGTT (up to 120 minutes from start of OGTT)
|
Measurement of serum free fatty acid levels (units: mmol/L) during OGTT.
A blood test will be done.
|
During OGTT (up to 120 minutes from start of OGTT)
|
Serum total cholesterol level
Time Frame: Before OGTT (baseline = 0 minutes)
|
Serum total cholesterol (units: mg/dL) after an overnight fast (> 8 hours).
A blood test will be done.
|
Before OGTT (baseline = 0 minutes)
|
Serum high-density lipoprotein (HDL) cholesterol level
Time Frame: Before OGTT (baseline = 0 minutes)
|
Serum high-density lipoprotein cholesterol (units: mg/dL) after an overnight fast (> 8 hours).
A blood test will be done.
|
Before OGTT (baseline = 0 minutes)
|
Serum low-density lipoprotein (LDL) cholesterol level
Time Frame: Before OGTT (baseline = 0 minutes)
|
Serum low-density lipoprotein cholesterol (units: mg/dL) after an overnight fast (> 8 hours).
A blood test will be done.
|
Before OGTT (baseline = 0 minutes)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joshua R Cook, MD, PhD, Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAU4674
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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