Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT01691196

Inflammation in Peritoneal Dialysis Patients: Effect of Obesity

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
University of Illinois at Chicago · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2012-09-01
Primary completion
2017-09-01
Completion
2017-09-01
First posted
2012-09-24
Last updated
2019-10-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01691196. Inclusion in this directory is not an endorsement.