Epigenetic Determinants of Peritoneal Fibrosis

NCT02513615 | Completed

• 1 other identifier: 14CECPDNA1006
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Peritoneal dialysis (PD) is a type of kidney replacement therapy for patients with chronic kidney disease where the peritoneal membrane is used to filter the blood. Exposure to PD fluid results in scarring of the peritoneal membrane and increased blood vessel growth. This condition can progress even when peritoneal dialysis is stopped. Therefore, the investigators hypothesize glucose in the dialysis fluid may result in DNA modifications called epigenetic changes. These changes modify how genes are expressed and how cells function. The investigators want to study these epigenetic changes and the effect on peritoneal membrane scarring, blood vessel growth and peritoneal membrane function.

Conditions

Peritoneal Fibrosis

Keywords

Fibrosis; Peritoneal Dialysis; Epigenetics; Peritoneal membrane injury; Glucose exposure

Outcome Measures

Primary Outcomes (1)

• DNA methylation pattern

  DNA methylation pattern will be measured after 12 months of glucose exposure compared with a baseline sample. Gene expression will be measured by Genome wide methylation analysis. In the incident patients, a within-subject analysis will be carried out between the naive and 12 month cell culture sample. Gene expression analysis will be performed with the statistical software R and "BioConductor", a collection of tools for gene expression analysis. Gene-level summaries from Human HT-12 BeadChip data will be generated using the widely used Bioconductor package lumi, which includes background correction, variance stabilization and normalization of expression data. The Linear Models for Microarray Analysis (LIMMA) package of Bioconductor will be used for differential expression analysis.

  12 months

Secondary Outcomes (1)

• DNA methylation and solute transport

  12 months

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 with end stage renal disease recently started on peritoneal dialysis. Patients will be over the age of 18.

You may qualify if:

• Patients with end stage renal disease recently started on peritoneal dialysis. Patients will be over the age of 18.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4a6, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A 15ml sample of PD fluid

MeSH Terms

Conditions

Peritoneal Fibrosis; Fibrosis

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter J Margetts, MD PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: July 31, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)