Clinical trial NCT01691196: Inflammation in Peritoneal Dialysis Patients: Effect of Obesity
Official title: Inflammation in Peritoneal Dialysis Patients: Effect of Obesity
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: End-Stage Renal Disease
Renal Disease, End-Stage
Renal Failure, End-Stage
Obesity
Keywords: Obesity
Peritoneal dialysis
Inflammation
Macrophages
Innate immunity
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing peritoneal dialysis

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. \> 18 years; and
2. peritoneal dialysis (PD) \> 6 months.

Exclusion Criteria:

1. infectious episode within 4 weeks; and
2. using immunosuppressive drugs

Primary outcomes:
measure: Plasma and dialysate levels of pro-inflammatory and anti-inflammatory molecules
timeFrame: 24 hours
Secondary outcomes:
measure: Peritoneal macrophage subphenotype
timeFrame: 24 hours
Other outcomes:
measure: Measurement of adiposity/obesity
timeFrame: 24 hours
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: UIC
name: Jerrold S Levine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UIC
name: Natalia Litbarg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UIC
name: Giamila Fantuzzi, PhD
role: PRINCIPAL_INVESTIGATOR
References: