PsoriasisNCT06242847
Role of Insulin Action in Psoriasis Pathogenesis
An observational study of Psoriasis and Plaque Psoriasis, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis, Plaque Psoriasis, Insulin Resistance
- What is being tested?
- Oral glucose tolerance test (OGTT) and Skin punch biopsy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2024to 12 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with plaque psoriasis but without diabetes mellitus
Who may be able to join
- 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:
Show all 22Show fewer
- 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.
Who cannot join
- Inability to provide informed consent in English or Spanish
- 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
Show all 28Show fewer
- 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
- 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 NOTE: Women not using any of the above forms of birth control may be included if they have a negative urine pregnancy test on the day of the study, before beginning any study procedures.
- Women currently pregnant
- Women currently breastfeeding
- Known, documented history, at the time of screening, of any of the following medical conditions:
- 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:
- 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.
- 13. 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.
- 14. 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
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.
Read the detailed description
Psoriasis exhibits a clear and robust epidemiologic association with type 2 diabetes mellitus (T2DM). Although T2DM may exacerbate psoriasis and/or complicate its treatment, we do not understand the mechanisms connecting them. As a starting point, psoriasis appears to worsen the insulin resistance (IR) that underlies T2DM. The study investigators hypothesize that the hyperinsulinemia that attempts to compensate for IR retains the ability to drive proliferation of psoriatic lesions. This would set up a vicious cycle in which psoriasis worsens IR, which in turn stimulates insulin hypersecretion that further intensifies psoriasis. In order to test this hypothesis, the investigators must first determine if insulin signaling in psoriatic lesions is actually hyperactive. The investigators therefore propose in this pilot study to elucidate the nature of insulin signaling in psoriasis by measuring phosphorylation of AKT, insulin's key intracellular signaling mediator, in skin biopsies. We will perform shave punch biopsies of lesional and non-lesional skin in overnight-fasted patients with psoriasis who are overweight or obese and therefore at risk of IR. Another set of biopsies will be taken during an oral glucose tolerance test that stimulates endogenous insulin secretion. The investigators expect that AKT phosphorylation will be attenuated in non-lesional skin of patients determined to have IR compared to those who are Insulin Sensitive (IS) or Insulin Intermediate (II), but that AKT phosphorylation will be preserved or even enhanced in lesional skin despite IR. Determining that insulin action is excessive in psoriatic lesions would suggest reducing insulin levels as a novel psoriasis treatment strategy that would also help to spare patients from difficult immunomodulatory treatments.
- Being tested
- Oral glucose tolerance test (OGTT), Skin punch biopsy
- Keywords
- Insulin, Insulin resistance, Psoriasis
- Medical subject headings
- Psoriasis, Insulin Resistance, Prediabetic State, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance test (OGTT)Diagnostic test
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.
Skin punch biopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Oral glucose tolerance test (OGTT); Procedure: Skin punch biopsy | |
| 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 Receives: Diagnostic Test: Oral glucose tolerance test (OGTT); Procedure: Skin punch biopsy | |
| 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. Receives: Diagnostic Test: Oral glucose tolerance test (OGTT); Procedure: Skin punch biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin insulin sensitivity: ratio of phosphorylated to total AKT in skin biopsies
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).
Measured: Up to 120 minutes from the start of OGTT
Secondary outcomes (5)
Serum triglyceride (TG) level during OGTT
Measurement of serum triglyceride level (units: mg/dL) during OGTT. A blood test will be done.
Measured: During OGTT (up to 120 minutes from start of OGTT)
Serum free fatty acid (FFA) levels during OGTT
Measurement of serum free fatty acid levels (units: mmol/L) during OGTT. A blood test will be done.
Measured: During OGTT (up to 120 minutes from start of OGTT)
Fasting plasma glucose level
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.
Measured: Before OGTT (baseline = 0 minutes), During OGTT (up to 120 minutes from start of OGTT)
Fasting serum insulin level
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.
Measured: Before OGTT (baseline = 0 minutes), During OGTT (up to 120 minutes from start of OGTT)
Fasting serum C-peptide level
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).
Measured: Before OGTT (baseline = 0 minutes), During OGTT (up to 120 minutes from start of OGTT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start2 Feb 2024
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
Why it stopped: The study's collaborating dermatologist left the institution, and so skin biopsies could no longer be performed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Cook, Columbia University
- Investigators
- Joshua R Cook, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242847
- Sponsor's protocol ID
- AAAU4674
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Insulin Action in Psoriasis Pathogenesis
- ClinicalTrials.gov ID
- NCT06242847
- Acronym / sponsor ID
- AAAU4674
- Keywords
- Insulin, Insulin resistance, Psoriasis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study's collaborating dermatologist left the institution, and so skin biopsies could no longer be performed.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Psoriasis exhibits a clear and robust epidemiologic association with type 2 diabetes mellitus (T2DM). Although T2DM may exacerbate psoriasis and/or complicate its treatment, we do not understand the mechanisms connecting them. As a starting point, psoriasis appears to worsen the insulin resistance (IR) that underlies T2DM. The study investigators hypothesize that the hyperinsulinemia that attempts to compensate for IR retains the ability to drive proliferation of psoriatic lesions. This would set up a vicious cycle in which psoriasis worsens IR, which in turn stimulates insulin hypersecretion that further intensifies psoriasis. In order to test this hypothesis, the investigators must first determine if insulin signaling in psoriatic lesions is actually hyperactive. The investigators therefore propose in this pilot study to elucidate the nature of insulin signaling in psoriasis by measuring phosphorylation of AKT, insulin's key intracellular signaling mediator, in skin biopsies. We will perform shave punch biopsies of lesional and non-lesional skin in overnight-fasted patients with psoriasis who are overweight or obese and therefore at risk of IR. Another set of biopsies will be taken during an oral glucose tolerance test that stimulates endogenous insulin secretion. The investigators expect that AKT phosphorylation will be attenuated in non-lesional skin of patients determined to have IR compared to those who are Insulin Sensitive (IS) or Insulin Intermediate (II), but that AKT phosphorylation will be preserved or even enhanced in lesional skin despite IR. Determining that insulin action is excessive in psoriatic lesions would suggest reducing insulin levels as a novel psoriasis treatment strategy that would also help to spare patients from difficult immunomodulatory treatments.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Insulin Sensitive (IS) with psoriasis | – | Diagnostic Test: Oral glucose tolerance test (OGTT), Procedure: Skin punch biopsyPatients 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 | – | Diagnostic Test: Oral glucose tolerance test (OGTT), Procedure: Skin punch biopsyPatients 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 | – | Diagnostic Test: Oral glucose tolerance test (OGTT), Procedure: Skin punch biopsyPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with plaque psoriasis but without diabetes mellitus
Key inclusion criteria (22 listed)
- 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):
Key exclusion criteria (28 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral glucose tolerance test (OGTT)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. | Diagnostic test | Insulin Intermediate (II) with psoriasis, Insulin Resistant (IR) with psoriasis, Insulin Sensitive (IS) with psoriasis |
| Skin punch biopsyPunch 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. | Procedure or surgery | Insulin Intermediate (II) with psoriasis, Insulin Resistant (IR) with psoriasis, Insulin Sensitive (IS) with psoriasis |
Primary outcome
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).
5 secondary outcomes
Serum triglyceride (TG) level during OGTT
Time frame: 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)
Fasting plasma glucose level
Time frame: 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)
Fasting serum C-peptide level
Time frame: Before OGTT (baseline = 0 minutes), During OGTT (up to 120 minutes from start of OGTT)
Results and safety
The study was stopped early (reason given: The study's collaborating dermatologist left the institution, and so skin biopsies could no longer be performed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua R Cook, MD, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Plaque Psoriasis, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study's collaborating dermatologist left the institution, and so skin biopsies could no longer be performed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin insulin sensitivity: ratio of phosphorylated to total AKT in skin biopsies (time frame: Up to 120 minutes from the start of OGTT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.