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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013830
Receipt No. R000015705
Scientific Title Lifestyle integrated intervention before and after living kidney transplantation for donors with obesity.
Date of disclosure of the study information 2014/05/15
Last modified on 2017/10/30

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Basic information
Public title Lifestyle integrated intervention before and after living kidney transplantation for donors with obesity.
Acronym Lifestyle intervention for donors of living kidney transplantation.
Scientific Title Lifestyle integrated intervention before and after living kidney transplantation for donors with obesity.
Scientific Title:Acronym Lifestyle intervention for donors of living kidney transplantation.
Region
Japan

Condition
Condition Living kidney transplant donor
Classification by specialty
Urology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effectiveness of integrative lifestyle intervention for living kidney transplant donor with obesity (BMI>25).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Weight loss to the ideal body composition before transplantation.
Key secondary outcomes Maintenance of ideal body weight and improved life style after transplantation.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Perform a lifestyle intervention, including nutritional assessment and the exercise guidelines for the donors who plan to do a living kidney transplant.
Term of intervention:
1.Weight reduction to appropriate weight 2.transplant operation
3.3 month follow-up after operation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Subjects who plan to do living kidney transplantation as donor.
2)Subjects whose BMI is 25 or more.
3)Subjects who plan to do kidney transplantation within 3 years.
4)The doctor in charge diagnose that subjects need to reduce their weight before surgery.
5)Subjects who are obtained with the prior written consent.
Key exclusion criteria 1)Subjects less than 20 years old.
2)Subjects who are pregnant or wish to become pregnant.
3)Subjects judged to be inappropriate for this study from the doctor in charge.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinori Ito
Organization Osaka University Graduate School of Medicine
Division name Department of Complementary and Alternative Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3498
Email juki@cam.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Asuka Yasueda
Organization Osaka University Graduate School of Medicine
Division name Department of Complementary and Alternative Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3498
Homepage URL
Email a-yasueda@cam.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School Department of Complementary and Alternative Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2014 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 04 Month 28 Day
Last modified on
2017 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015705

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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