Kidney TransplantationNCT01157884
Change of Body Composition After Kidney Transplantation in Korea
An observational study of Kidney Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The graft survival in kidney transplantation has been improving after the introduction of new immunosuppressive agents. Therefore, other complications after transplantation are concerned; one of those is obesity. Several factors are attributable to obesity in kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Kidney Transplantation
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2009to Sep 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: recieved kidney transplantation in the Seoul National University Hospital
Who may be able to join
- aged 20 years and over
Who cannot join
- history of previous transplantation
- co-transplantation with other organs
- neuropsychological problem with diet (such as anorexia nervosa, bulimia)
Trial locations and contacts
1 site in 1 country.
About this study
The graft survival in kidney transplantation has been improving after the introduction of new immunosuppressive agents. Therefore, other complications after transplantation are concerned; one of those is obesity. Several factors are attributable to obesity in kidney transplant recipients.
The body composition such as fat mass and lean mass is important concept in overweight patients. Some studies have been conducted on the change of body composition in kidney transplants. However, all of them are studied among Caucasians or using dual energy X-ray absorptiometry (DEXA).
In this study, the investigators plan to study the body composition among Asian kidney transplant recipients using the bioelectrical impedance analysis (BIA).
- Conditions
- Kidney Transplantation
- Keywords
- body composition, obesity, kidney transplantation
- Medical subject headings
- Obesity
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 |
|---|---|---|
| Kidney Transplantation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of body composition
fat mass, lean mass
Measured: 2 weeks, 1/3/6/9/12 months after transplantation
Secondary outcomes (2)
weight, waist circumference
Measured: 2 weeks, 1/3/6/9/12 months after transplantation
cholesterol, CRP
Measured: 2 weeks, 1/3/6/9/12 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startSep 2009
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yon Su Kim, Seoul National University Hospital
- Investigators
- Yon Su Kim, M.D., Ph.D., Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157884
- Sponsor's protocol ID
- SNUH-001-YH
- Status last verified
- Jan 2012
- First submitted
- 9 Jun 2010
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Body Composition After Kidney Transplantation in Korea
- ClinicalTrials.gov ID
- NCT01157884
- Acronym / sponsor ID
- SNUH-001-YH
- Conditions
- Kidney Transplantation
- Keywords
- body composition, obesity, kidney transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 7 Jul 2010 (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.
The graft survival in kidney transplantation has been improving after the introduction of new immunosuppressive agents. Therefore, other complications after transplantation are concerned; one of those is obesity. Several factors are attributable to obesity in kidney transplant recipients.
The body composition such as fat mass and lean mass is important concept in overweight patients. Some studies have been conducted on the change of body composition in kidney transplants. However, all of them are studied among Caucasians or using dual energy X-ray absorptiometry (DEXA).
In this study, the investigators plan to study the body composition among Asian kidney transplant recipients using the bioelectrical impedance analysis (BIA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney Transplantation | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- recieved kidney transplantation in the Seoul National University Hospital
Key inclusion criteria (1 listed)
- aged 20 years and over
Key exclusion criteria (3 listed)
- history of previous transplantation
- co-transplantation with other organs
- neuropsychological problem with diet (such as anorexia nervosa, bulimia)
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
change of body composition
Time frame: 2 weeks, 1/3/6/9/12 months after transplantation
fat mass, lean mass
2 secondary outcomes
weight, waist circumference
Time frame: 2 weeks, 1/3/6/9/12 months after transplantation
cholesterol, CRP
Time frame: 2 weeks, 1/3/6/9/12 months after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
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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.
Yon Su Kim, M.D., Ph.D. study chair
Seoul National University Hospital
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 Kidney Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
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 1 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: finished, as of the sponsor's last update on 5 Jan 2012. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of body composition (time frame: 2 weeks, 1/3/6/9/12 months after transplantation). 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 5 Jan 2012.