Inflammation in Peritoneal Dialysis Patients: Effect of Obesity
|ClinicalTrials.gov Identifier: NCT01691196|
Recruitment Status : Unknown
Verified May 2015 by Jerrold S. Levine, University of Illinois at Chicago.
Recruitment status was: Recruiting
First Posted : September 24, 2012
Last Update Posted : May 28, 2015
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.
|Condition or disease|
|End-Stage Renal Disease Renal Disease, End-Stage Renal Failure, End-Stage Obesity|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Inflammation in Peritoneal Dialysis Patients: Effect of Obesity|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2017|
- Plasma and dialysate levels of pro-inflammatory and anti-inflammatory molecules [ Time Frame: 24 hours ]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.
- Peritoneal macrophage subphenotype [ Time Frame: 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
- Measurement of adiposity/obesity [ Time Frame: 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).
Biospecimen Retention: Samples Without DNA
Blood Collection: Venous blood after overnight fast will include: (1) heparinized tube (green top) for whole blood (WB) cultures; (2) EDTA tube (lavender top) for CBC and measurement of cytokines and adipokines, and (3) serum-separator (red top) for determination of lipid panel, glucose, insulin, and hemoglobin A1c. Glucose and insulin will be used to calculate HOMA-IR (index of insulin resistance).
Collection of peritoneal dialysis effluent (PDE): To minimize variability, 2.5% glucose peritoneal dialysis (PD) solution and 4h dwell time will be used for all patients on test day. Immediately after collection, PDE will be chilled before further processing.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691196
|Contact: Natalia Litbarg, MDfirstname.lastname@example.org|
|Contact: Giamila Fantuzzi, PhDemail@example.com|
|United States, Illinois|
|University of Illinois at Chicago||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Natalia Litbarg, MD 312-996-6736 firstname.lastname@example.org|
|Contact: Giamila Fantuzzi, PhD 312-413-5398 email@example.com|
|Principal Investigator: Jerrold S Levine, MD|
|Principal Investigator: Natalia Litbarg, MD|
|Principal Investigator: Giamila Fantuzzi, PhD|
|Principal Investigator:||Jerrold S Levine, MD||UIC|
|Principal Investigator:||Natalia Litbarg, MD||UIC|
|Principal Investigator:||Giamila Fantuzzi, PhD||UIC|