The Effects Nutrition Status and Body Composition on HD Patients' Outcome

Malnutrition Clinical Trial

Official title:

The Effects Nutrition Status and Body Composition on HD Patients' Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01945320
• Other study ID #: 201112008RIC
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2013
• Last updated: April 11, 2014
• Start date: March 2012
• Est. completion date: December 2016

Study information

• Verified date: April 2014
• Source: National Taiwan University Hospital
• Contact: Jenq-Wen Huang, Doctor
• Phone: +886-2-2312-3456
• Email: 007378[@]ntuh.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

A prospective long-term follow up of hemodialysis (HD) patients' outcome correlates with nutritional status and body composition. We will evaluate the body composition change among HD patients every three months with bioelectrical impedance analysis (BIA). The change of body composition will correlated with other clinical data including nutritional, inflammatory parameters and survival.

Description:

Wasting and malnutrition are common and serious complications in patients on hemodialysis 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 hemodialysis. We will conduct a prospective long-term follow up of HD 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 and monthly biochemical data are collected to analyze. An additional blood sample of 8 ml will be collected every 3 months during the BIA survey for other inflammatory cytokines and nutritional markers such as adiponectin, leptin, ghrelin, prealbumin, fetuin A, fructosamine, IL-1, IL-6 and transferrin. The follow up period will be as long as possible and the last recruited into this study is in the Dec. 2016. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients at National Taiwan University Hospital

• Patients who have received hemodialysis more than 3 months

• Patients who sign the informed consents

Exclusion Criteria:

• Patients who have received hemodialysis less than 3 months

• Patients who refuse to sign informed consents

• Patients who refuse to draw additional blood for research

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Body Composition
• Malnutrition
• Nutritional Wasting

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the correlation between the change of body composition by bioelectrical impedance analysis (BIA) with other clinical data including nutritional, inflammatory parameters and survival.		Participants will be tracked once every 6 months, up to 5 years to be followed.	Yes