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Insulin Sensitive (IS) with psoriasis for Prediabetes

N/A
Recruiting
Led By Joshua R Cook, MD, PhD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 120 minutes from the start of ogtt
Awards & highlights

Study 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.

Eligible Conditions
  • Plaque Psoriasis
  • Prediabetes
  • Insulin Resistance
  • Psoriasis
  • Obesity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 120 minutes from the start of ogtt
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 120 minutes from the start of ogtt for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fasting plasma glucose level
Fasting serum C-peptide level
Fasting serum insulin level
+1 more
Secondary outcome measures
Serum free fatty acid (FFA) levels during OGTT
Serum high-density lipoprotein (HDL) cholesterol level
Serum low-density lipoprotein (LDL) cholesterol level
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Insulin Sensitive (IS) with psoriasisExperimental Treatment2 Interventions
Patients with plaque psoriasis and overweight/obese (BMI 25-35) found to have: Hemoglobin A1c < 5.7% Fasting plasma glucose: < 95 mg/dL Fasting serum insulin: < 10 micro-international units per milliliter (μIU/mL)
Group II: Insulin Resistant (IR) with psoriasisExperimental Treatment2 Interventions
Patients with plaque psoriasis and overweight/obese (BMI 25-35) found to have: Hemoglobin A1c < 6.5% Fasting plasma glucose: 80-125 mg/dL Fasting serum insulin: ≥ 15 μIU/mL
Group III: Insulin Intermediate (II) with psoriasisExperimental Treatment2 Interventions
Patients with plaque psoriasis and overweight/obese (BMI 25-35) found to have: Hemoglobin A1c < 6.5% Fasting plasma glucose: 80-125 mg/dL Fasting serum insulin: 10-14 μIU/mL
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral glucose tolerance test (OGTT)
2012
Completed Phase 1
~210

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,815 Total Patients Enrolled
Joshua R Cook, MD, PhDPrincipal InvestigatorColumbia University
5 Previous Clinical Trials
167 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Role of Insulin Action in Psoriasis Pathogenesis
Joshua Cook 2024. "Role of Insulin Action in Psoriasis Pathogenesis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06242847.
~12 spots leftby Apr 2025
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