Pilot Study Characterizing Adipose Tissue Leukocytes by Flow Cytometry/Microscopy in Lean, Obese and Psoriatic Subjects

A Pilot Study to Characterize Adipose Tissue Leukocytes by Flow Cytometry and Microscopy in Lean, Obese and Psoriatic Subjects (Lean/Obese)

Obesity is an insulin resistance-associated metabolic disorder which is a hallmark of and risk factor for type 2 diabetes and the metabolic syndrome, often linked to cardiovascular disease, certain cancers and inflammatory diseases.The phenotyping of subcutaneous adipose tissue (SAT) hematopoetic cells from obese subjects by flow cytometry, microscopy and gene expression will enable us to identify inflammation in this tissue and may help us to understand the causes and consequences of obesity in order to determine how these cells might be implicated in the initiation and/or progression of the aforementioned diseases.

Study Overview

• Status: Terminated
• Conditions: Obesity; Psoriasis
• Intervention / Treatment: Procedure: Adipose tissue biopsy (fat biopsy)

Detailed Description

Obesity is an insulin resistance-associated metabolic disorder which is a hallmark of and risk factor for type 2 diabetes and the metabolic syndrome. It is also often linked to cardiovascular disease, certain cancers (e.g., colorectal, esophageal, endometrial, and ovarian), and inflammatory diseases (e.g., psoriasis, osteoarthritis,inflammatory bowel disease).The phenotyping of subcutaneous adipose tissue (SAT) hematopoetic cells from obese subjects by flow cytometry, microscopy and gene expression will enable us to identify inflammation in this tissue and may help us to understand the causes and consequences of obesity in order to determine how these cells might be implicated in the initiation and/or progression of the aforementioned diseases.

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • The Rockefeller University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Obesity and psoriasis are characterized by infiltration of inflammatory cells (leukocytes) in SAT and skin, respectively. We expect that SAT in obese psoriasis subjects will have infiltrating inflammatory leukocytes because of obesity, and that these infiltrating leukocytes might be different and/or increased in numbers by the pathology of psoriasis

Description

Inclusion Criteria:

• Psoriatic lean cohort (BMI between 18-24.9 Kg/m2): moderate to severe plaque-type, at least 5% of BSA
• Psoriatic obese cohort (BMI between 30-40 Kg/m2): moderate to severe plaque-type, at least 5% of BSA
• Lean/non-psoriatic cohort: BMI between 18-24.9 Kg/m2
• Overweight/obese non-psoriatic cohort: BMI between 30-40 Kg/m2
• Subjects must be 18-65 years of age

Exclusion Criteria:

• Having received any systemic treatment for psoriasis within the last 30 days
• history of bleeding disorder
• weight loss of 10 pounds in the last four weeks
• current smoker
• Known diagnosis of any unrelated autoimmune disease or inflammatory disease ( i.e. lupus, atopic dermatitis, rheumatoid arthritis).
• Currently taking NSAIDS, aspirin, (if > once a week, stopped <30 days ago). Aspirin 81mg may be permitted if the Framingham Risk Score is < 10
• Having received any anti-inflammatory medication within the last 30 days
• Current use of any anti-coagulants
• LFTs > 2 x upper normal limits
• HIV infection
• Pregnant
• Less than 6 weeks post partum
• history of cardiovascular disease (MI, CHF, CVA)
• Any cancer diagnosis within the last 5 years
• Symptoms of acute illness such as upper respiratory infection, bronchitis, gastroenteritis, or fever within 3 days of Visit 1
• Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data
• ingestion of DHA or fish oil within last 90 days
• hypertension as defined as > 140 systolic and > 90 diastolic after 10 minutes of resting on 2 antihypertensives
• Use of statins within the last 30 days

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
lean (BMI≤ 24.9 Kg/m2); Adipose tissue biopsy (fat biopsy) in 9 lean (BMI≤ 24.9 Kg/m2)	Procedure: Adipose tissue biopsy (fat biopsy); An adipose tissue biopsy will be performed after a 10-12 hour overnight fast. A small sample of fat tissue will be removed from the subject for gene expression analysis. A subcutaneous fat biopsy (~3 ml) will be obtained from the lower abdomen following local anesthesia.
obese (BMI= 30-40 Kg/m2); 9 obese (BMI= 30-40 Kg/m2)	Procedure: Adipose tissue biopsy (fat biopsy); An adipose tissue biopsy will be performed after a 10-12 hour overnight fast. A small sample of fat tissue will be removed from the subject for gene expression analysis. A subcutaneous fat biopsy (~3 ml) will be obtained from the lower abdomen following local anesthesia.
psoriatic lean; 9 psoriatic lean	Procedure: Adipose tissue biopsy (fat biopsy); An adipose tissue biopsy will be performed after a 10-12 hour overnight fast. A small sample of fat tissue will be removed from the subject for gene expression analysis. A subcutaneous fat biopsy (~3 ml) will be obtained from the lower abdomen following local anesthesia.
psoriatic obese; 9 psoriatic obese	Procedure: Adipose tissue biopsy (fat biopsy); An adipose tissue biopsy will be performed after a 10-12 hour overnight fast. A small sample of fat tissue will be removed from the subject for gene expression analysis. A subcutaneous fat biopsy (~3 ml) will be obtained from the lower abdomen following local anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers for phenotyping a new type of leukocyte	Biomarkers for phenotyping a new type of leukocyte	5 years

Collaborators and Investigators

• Sponsor: Rockefeller University
• Investigators: Principal Investigator: Juana Gonzalez, Rockefeller Univesrity

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: May 14, 2013
• First Posted (Estimate): May 17, 2013

Study Record Updates

• Last Update Posted (Estimate): December 21, 2015
• Last Update Submitted That Met QC Criteria: December 18, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Obesity; Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: JUG-0799