Change of Body Composition After Kidney Transplantation i... | NCT01157884

Studies
Change of Body Composition After Kidney Transplantation in Korea

NCT01157884

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jan 5, 2012Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Kidney Transplantation

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Aug 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Jun 9, 2010

First Submission Date that Met QC Criteria

Jul 6, 2010

First Posted Date

Jul 7, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2012

Last Update Posted Date

Jan 5, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Label	Type	Description	Intervention Names
Kidney Transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of body composition	fat mass, lean mass	2 weeks, 1/3/6/9/12 months after transplantation

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 20 years and over

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

recieved kidney transplantation in the Seoul National University Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yon Su Kim, M.D., Ph.D.	Seoul National University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided