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

NCT ID: NCT01856647

Last Updated: 2015-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Psoriasis Obesity

Keywords

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Psoriasis Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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lean (BMI≤ 24.9 Kg/m2)

Adipose tissue biopsy (fat biopsy) in 9 lean (BMI≤ 24.9 Kg/m2)

Adipose tissue biopsy (fat biopsy)

Intervention Type PROCEDURE

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)

Adipose tissue biopsy (fat biopsy)

Intervention Type PROCEDURE

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

Adipose tissue biopsy (fat biopsy)

Intervention Type PROCEDURE

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

Adipose tissue biopsy (fat biopsy)

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rockefeller University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juana Gonzalez

Role: PRINCIPAL_INVESTIGATOR

Rockefeller Univesrity

Locations

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The Rockefeller University

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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JUG-0799

Identifier Type: -

Identifier Source: org_study_id