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Clinical Trials/NCT01856647
NCT01856647
Terminated
Not Applicable

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

Rockefeller University1 site in 1 country1 target enrollmentStarted: February 2013Last updated:

Overview

Phase
Not Applicable
Status
Terminated
Enrollment
1
Locations
1
Primary Endpoint
Biomarkers for phenotyping a new type of leukocyte

Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Biomarkers for phenotyping a new type of leukocyte

Time Frame: 5 years

Biomarkers for phenotyping a new type of leukocyte

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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