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

Terminated

• Conditions: Obesity; Psoriasis
• Interventions: Procedure: Adipose tissue biopsy (fat biopsy)

• Registration Number: NCT01856647
• Lead Sponsor: Rockefeller University

Brief Summary

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.

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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-17
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-18
• Last Update Posted: 2015-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
obese (BMI= 30-40 Kg/m2)	Adipose tissue biopsy (fat biopsy)	9 obese (BMI= 30-40 Kg/m2)
lean (BMI≤ 24.9 Kg/m2)	Adipose tissue biopsy (fat biopsy)	Adipose tissue biopsy (fat biopsy) in 9 lean (BMI≤ 24.9 Kg/m2)
psoriatic lean	Adipose tissue biopsy (fat biopsy)	9 psoriatic lean
psoriatic obese	Adipose tissue biopsy (fat biopsy)	9 psoriatic obese

Primary Outcome Measures

Name	Time	Method
Biomarkers for phenotyping a new type of leukocyte	5 years	Biomarkers for phenotyping a new type of leukocyte

Trial Locations

Locations (1)

The Rockefeller University; 🇺🇸 New York, New York, United States