NCT01157884

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 7, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

1.9 years

First QC Date

June 9, 2010

Last Update Submit

January 3, 2012

Conditions

Kidney Transplantation

Keywords

body compositionobesitykidney transplantation

Outcome Measures

Primary Outcomes (1)

  • change of body composition

    fat mass, lean mass

    2 weeks, 1/3/6/9/12 months after transplantation

Secondary Outcomes (2)

  • weight, waist circumference

    2 weeks, 1/3/6/9/12 months after transplantation

  • cholesterol, CRP

    2 weeks, 1/3/6/9/12 months after transplantation

Study Arms (1)

Kidney Transplantation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

recieved kidney transplantation in the Seoul National University Hospital

You may qualify if:

  • aged 20 years and over

You may not qualify if:

  • history of previous transplantation
  • co-transplantation with other organs
  • neuropsychological problem with diet (such as anorexia nervosa, bulimia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Biospecimen

Retention: NONE RETAINED

serum: total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, C-reactive protein (CRP)

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yon Su Kim, M.D., Ph.D.

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 9, 2010

First Posted

July 7, 2010

Study Start

September 1, 2009

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

KR(1)