Body CompositionNCT01945320
The Effects Nutrition Status and Body Composition on HD Patients' Outcome
An observational study of Body Composition and Nutritional Wasting, run by National Taiwan University Hospital at 1 site in Taiwan.
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). Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Body Composition, Nutritional Wasting, Malnutrition
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2012to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HD patients
Who may be able to join
- Patients at National Taiwan University Hospital
- Patients who have received hemodialysis more than 3 months
- Patients who sign the informed consents
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 10002
Jenq-Wen Huang, Doctor, +886-2-2312-3456 ext. 63288, 007378@ntuh.gov.tw
About this study
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.
Read the detailed 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.
- Conditions
- Body Composition, Nutritional Wasting, Malnutrition
- Keywords
- hemodialysis, wasting and malnutrition, nutrition status, bioelectrical impedance analysis, body composition
- Medical subject headings
- Malnutrition, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HD-BCM | 1. Patients at National Taiwan University Hospital 2. Patients who have received HD more than 3 months 3. Patients who sign the informed consents 4. Patients who aged between 20-90 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be tracked once every 6 months, up to 5 years to be followed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startMar 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body CompositionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945320
- Sponsor's protocol ID
- 201112008RIC
- Status last verified
- Apr 2014
- First submitted
- 9 Sep 2013
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Nutrition Status and Body Composition on HD Patients' Outcome
- ClinicalTrials.gov ID
- NCT01945320
- Acronym / sponsor ID
- 201112008RIC
- Conditions
- Body Composition, Nutritional Wasting, Malnutrition
- Keywords
- hemodialysis, wasting and malnutrition, nutrition status, bioelectrical impedance analysis, body composition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 18 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HD-BCM | – | –1. Patients at National Taiwan University Hospital 2. Patients who have received HD more than 3 months 3. Patients who sign the informed consents 4. Patients who aged between 20-90 years |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HD patients
Key inclusion criteria (3 listed)
- Patients at National Taiwan University Hospital
- Patients who have received hemodialysis more than 3 months
- Patients who sign the informed consents
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: Participants will be tracked once every 6 months, up to 5 years to be followed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Composition and Nutritional Wasting, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenq-Wen Huang, Doctor (+886-2-2312-3456 ext. 63288, 007378@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Participants will be tracked once every 6 months, up to 5 years to be followed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2014.