Pilot Study Characterizing Adipose Tissue Leukocytes by Flow Cytometry/Microscopy in Lean, Obese and Psoriatic Subjects
18 december 2015 bijgewerkt door: Rockefeller University
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, 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.
Studie Overzicht
Toestand
Beëindigd
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10065
- The Rockefeller University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
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
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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lean (BMI≤ 24.9 Kg/m2)
Adipose tissue biopsy (fat biopsy) in 9 lean (BMI≤ 24.9 Kg/m2)
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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.
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obese (BMI= 30-40 Kg/m2)
9 obese (BMI= 30-40 Kg/m2)
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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.
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psoriatic lean
9 psoriatic lean
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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
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Biomarkers for phenotyping a new type of leukocyte
Tijdsspanne: 5 years
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Biomarkers for phenotyping a new type of leukocyte
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5 years
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Juana Gonzalez, Rockefeller Univesrity
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 februari 2013
Primaire voltooiing (Werkelijk)
1 december 2015
Studie voltooiing (Werkelijk)
1 december 2015
Studieregistratiedata
Eerst ingediend
14 mei 2013
Eerst ingediend dat voldeed aan de QC-criteria
14 mei 2013
Eerst geplaatst (Schatting)
17 mei 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
21 december 2015
Laatste update ingediend die voldeed aan QC-criteria
18 december 2015
Laatst geverifieerd
1 december 2015
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- JUG-0799
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .