UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013830 |
|---|---|
| Receipt number | 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 10:35:30 |
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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
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
a-yasueda@cam.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School Department of Complementary and Alternative Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015705
