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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01856647
• Other study ID #: JUG-0799
• Status: Terminated
• Phase: N/A
• First received: May 14, 2013
• Last updated: December 18, 2015
• Start date: February 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity
• Psoriasis

Intervention

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.

Locations

Country	Name	City	State
United States	The Rockefeller University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Rockefeller University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers for phenotyping a new type of leukocyte	Biomarkers for phenotyping a new type of leukocyte	5 years	No