Inflammation in Peritoneal Dialysis Patients: Effect of Obesity

NCT01691196 | Withdrawn DMC

• 2 other identifiers: 2012-0506Baxter/UIC Ref#2012-04881
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

End-Stage Renal Disease; Renal Disease, End-Stage; Renal Failure, End-Stage; Obesity

Keywords

Obesity; Peritoneal dialysis; Inflammation; Macrophages; Innate immunity

Outcome Measures

Primary Outcomes (1)

• Plasma and dialysate levels of pro-inflammatory and anti-inflammatory molecules

  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.

  24 hours

Secondary Outcomes (1)

• Peritoneal macrophage subphenotype

  24 hours

Other Outcomes (1)

• Measurement of adiposity/obesity

  24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing peritoneal dialysis

You may qualify if:

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

You may not qualify if:

• infectious episode within 4 weeks; and
• using immunosuppressive drugs

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

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.

MeSH Terms

Conditions

Kidney Failure, Chronic; Obesity; Inflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Jerrold S Levine, MD

  UIC

  PRINCIPAL INVESTIGATOR

• Natalia Litbarg, MD

  UIC

  PRINCIPAL INVESTIGATOR

• Giamila Fantuzzi, PhD

  UIC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 24, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 29, 2019

Record last verified: 2019-10

Locations

US (1)