Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been terminated.
(Low enrollment)
Sponsor:
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT01856647
First received: May 14, 2013
Last updated: December 18, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention
Psoriasis
Obesity
Procedure: Adipose tissue biopsy (fat biopsy)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study to Characterize Adipose Tissue Leukocytes by Flow Cytometry and Microscopy in Lean, Obese and Psoriatic Subjects (Lean/Obese)

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Biomarkers for phenotyping a new type of leukocyte [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Biomarkers for phenotyping a new type of leukocyte


Biospecimen Retention:   Samples Without DNA
Fat Biopsy

Enrollment: 1
Study Start Date: February 2013
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01856647

Locations
United States, New York
The Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: Juana Gonzalez Rockefeller Univesrity
  More Information

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT01856647     History of Changes
Other Study ID Numbers: JUG-0799 
Study First Received: May 14, 2013
Last Updated: December 18, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
Psoriasis
Obesity

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on December 09, 2016