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


N/A
18 Years
65 Years
Open (Enrolling)
Both
Healthy Volunteers, Psoriasis, Obesity

Thank you

Trial Information

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. 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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Biomarkers for phenotyping a new type of leukocyte

Outcome Description:

Biomarkers for phenotyping a new type of leukocyte

Outcome Time Frame:

5 years

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

JUG-0799

NCT ID:

NCT01856647

Start Date:

February 2013

Completion Date:

February 2015

Related Keywords:

  • Healthy Volunteers
  • Psoriasis
  • Obesity
  • Healthy Volunteers
  • Psoriasis
  • Obesity
  • Obesity
  • Psoriasis

Name

Location

The Rockefeller UniversityNew York, New York  10065