Trials Sponsors Conditions Drugs Pricing

Conditions

Insulin Resistance Overweight and Obesity Plaque Psoriasis PreDiabetes Psoriasis

Keywords

InsulinInsulin resistancePsoriasis

Outcome Measures

Primary Outcomes (1)

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).
Up to 120 minutes from the start of OGTT

Secondary Outcomes (5)

Serum triglyceride (TG) level during OGTT
During OGTT (up to 120 minutes from start of OGTT)
Serum free fatty acid (FFA) levels during OGTT
During OGTT (up to 120 minutes from start of OGTT)

Study Arms (3)

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.

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

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.

Interventions

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.

Insulin Intermediate (II) with psoriasisInsulin Resistant (IR) with psoriasisInsulin Sensitive (IS) with psoriasis

Skin punch biopsyProcedure

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with plaque psoriasis but without diabetes mellitus

You may qualify if:

Body mass index of 25.0-40.0 kg/m2

Sponsors & Collaborators

Columbia University
Otherlead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Blood samples during OGTT: fasting and at 120 min after ingestion of 75 g of glucose * Skin punch biopsies of lesional (psoriatic) and non-lesional skin taken while fasting and at 120 min after ingestion of 75 g glucose

MeSH Terms

Conditions

PsoriasisInsulin ResistancePrediabetic StateOverweightObesity

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes Mellitus

Study Officials

Joshua R Cook, MD, PhD
Columbia University
PRINCIPAL INVESTIGATOR

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor of Medicine

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 5, 2024

Study Start

February 2, 2024

Actual (reported)

Study Stopped

Role of Insulin Action in Psoriasis Pathogenesis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

Insulin Sensitive (IS) with psoriasis

Insulin Intermediate (II) with psoriasis

Insulin Resistant (IR) with psoriasis

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

Insulin Sensitive (IS) with psoriasis

Insulin Intermediate (II) with psoriasis

Insulin Resistant (IR) with psoriasis

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations