Inflammation in Peritoneal Dialysis Patients: Effect of Obesity
28. oktober 2019 opdateret af: Jerrold S. Levine, University of Illinois at Chicago
Our study addresses the following research question: What is the role of obesity in modulating inflammation and innate immune function, as well as the overall responsiveness of innate immune cells (such as macrophages, neutrophils, and other peripheral leukocytes) in patients undergoing peritoneal dialysis?
The investigators hypothesize that obesity will lead to increased inflammation in patients undergoing peritoneal dialysis.
Studieoversigt
Status
Trukket tilbage
Detaljeret beskrivelse
Chronic inflammation is highly prevalent in ESRD and associated with adverse outcomes.
For example, chronic exposure of the peritoneal cavity to PD solution leads to induction of cytokines and other inflammatory mediators, generating peritoneal membrane inflammation which results in functional decline of ultrafiltration.
Obesity is characterized by a state of chronic low-grade systemic inflammation stemming from expanded adipose tissue mass.
Animal studies from our group and others suggest that obesity is associated with exacerbated prolonged inflammatory responses in the peritoneal cavity.
The shifting demographic characteristics of the ESRD population, with a rise in elderly patients and those with obesity, is as a significant challenge for management of dialysis patients.
Specifically, a 2-fold increase in the percentage of obese patients in the ESRD population has been reported.
The caloric burden of PD glucose-containing solutions adds an additional risk for development or exacerbation of obesity and diabetes in patients using this dialysis modality.
Few studies have directly evaluated the association between degree of adiposity and inflammation in PD patients.
Data obtained from the proposed experiments will help clarify the connection between obesity and risk factors for cardiovascular and infectious diseases in the PD population.
These data will also further our knowledge of the basic pathophysiology of both obesity and ESRD and enhance our understanding of factors involved in successful delivery of PD. Results may lead to enhanced nutritional recommendations for PD patients and/or the use of low-glucose or non-glucose alternatives, with a resultant reduction in local and/or systemic inflammation and CVD and other risk factors.
Undersøgelsestype
Observationel
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- University of Illinois at Chicago
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients undergoing peritoneal dialysis
Beskrivelse
Inclusion Criteria:
- > 18 years; and
- peritoneal dialysis (PD) > 6 months.
Exclusion Criteria:
- infectious episode within 4 weeks; and
- using immunosuppressive drugs
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Plasma and dialysate levels of pro-inflammatory and anti-inflammatory molecules
Tidsramme: 24 hours
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Peritoneal dialysate effluent (PDE) and peripheral blood will be obtained from peritoneal dialysis (PD) subjects.
Levels of pro- and anti-inflammatory cytokines, chemokines, adipokines, and acute-phase reactants will be evaluated in PDE and plasma.
The ability of peripheral leukocytes to respond to microbial stimuli will be studied using whole blood cultures.
We predict percentage of body fat will be significantly associated with higher levels of pro-inflammatory factors both systemically and locally and with reduced ability of peripheral leukocytes to respond to microbial stimuli.
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24 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Peritoneal macrophage subphenotype
Tidsramme: 24 hours
|
The composition of leukocytes from peritoneal dialysate effluent (PDE) will be analyzed to evaluate the absolute and relative amounts of leukocyte subclasses.
The phenotype of peritoneal macrophages (pMac) will be evaluated by flow cytometry, by real time RT-PCR, and by measurement of mediators characteristic of each activation type following ex vivo culture.
We predict that we will observe a significant shift from an anti- to a pro-inflammatory pMac phenotype as adiposity increases
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24 hours
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Measurement of adiposity/obesity
Tidsramme: 24 hours
|
DXA (dual energy X-ray absorptiometry) will be conducted at UIC body composition laboratory using Hologic 4500 W Elite Scan.
Values from DXA scans will be primary method for evaluation of adiposity.
Height and weight will be measured by nurse to calculate body mass index (BMI).
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24 hours
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Jerrold S Levine, MD, UIC
- Ledende efterforsker: Natalia Litbarg, MD, UIC
- Ledende efterforsker: Giamila Fantuzzi, PhD, UIC
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2012
Primær færdiggørelse (Faktiske)
1. september 2017
Studieafslutning (Faktiske)
1. september 2017
Datoer for studieregistrering
Først indsendt
17. september 2012
Først indsendt, der opfyldte QC-kriterier
19. september 2012
Først opslået (Skøn)
24. september 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. oktober 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. oktober 2019
Sidst verificeret
1. oktober 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2012-0506 (Anden identifikator: M D Anderson Cancer Center)
- Baxter/UIC Ref#2012-04881 (Anden identifikator: Baxter)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .