The Effects Nutrition Status and Body Composition On Peritoneal Dialysis Outcome

April 11, 2014 updated by: National Taiwan University Hospital
A prospective long-term follow up of peritoneal dialysis patients' outcome correlates with nutritional status and body composition.

Study Overview

Status

Unknown

Conditions

Detailed Description

Wasting and malnutrition are common and serious complications in patients on peritoneal dialysis and are strongly associated with adverse outcomes. Techniques for assessing nutrition have limitations and, due to metabolic effects and confounding effects of altered hydration and other body composition abnormalities, these limitations are greater in the context of renal failure. Bioelectrical impedance analysis is a promising method for the objective assessment and monitoring of body composition. Body composition techniques subdivide the body into compartments on the basis of differing physical properties. The different compartments reflect hydration, nutrition/wasting, body fat, and bone mineral content, which are all of great importance in patients on peritoneal dialysis. We will conduct a prospective long-term follow up of PD patients' outcome correlates with nutritional status and body compositions. The patients will receive BIA every three months, and other routine clinical data such as dialysis adequacy, peritoneal equilibration test and monthly biochemical data are collected to analyze. An additional blood sample 8 ml and 5 ml dialysate of overnight, 0 hour, 2 hour and 4 hour will be collected during annual PET for other inflammatory cytokines and nutritional markers such as adiponectin, leptin, ghrelin, prealbumin and transferrin. The follow up period will be as long as possible and the last recruited into this study is in the Aug 2014. These data will be used for the morbidity and mortality analysis to see if body compositions will be more useful and timely than the other nutritional parameters.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

PD patients

Description

Inclusion Criteria:

  1. Patients at National Taiwan University Hospital
  2. Patients who have received PD more than 3 months
  3. Patients who sign the informed consents

Exclusion Criteria:

  1. Patients who have received PD less than 3 months
  2. Patients who refuse to sign informed consents
  3. Patients who refuse to draw additional blood for research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
PD-BCM
  1. Patients at National Taiwan University Hospital (NTUH)
  2. Patients who have received PD more than 3 months
  3. Patients who sign the informed consents
  4. Patients who aged between 20-90 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure BCM could be a nutrition status marker
Time Frame: 5 yrs
5 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

December 1, 2016

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

October 5, 2009

First Submitted That Met QC Criteria

October 5, 2009

First Posted (Estimate)

October 6, 2009

Study Record Updates

Last Update Posted (Estimate)

April 14, 2014

Last Update Submitted That Met QC Criteria

April 11, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200906084R

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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