UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030878 |
|---|---|
| Receipt number | R000035255 |
| Scientific Title | Effect of Diet and Exercise Therapy on Circulating Extracellular Vesicles |
| Date of disclosure of the study information | 2018/01/19 |
| Last modified on | 2023/01/23 16:27:10 |
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Basic information
Public title
Effect of Diet and Exercise Therapy on Circulating Extracellular Vesicles
Acronym
Diet/Exercise and EVs
Scientific Title
Effect of Diet and Exercise Therapy on Circulating Extracellular Vesicles
Scientific Title:Acronym
Diet/Exercise and EVs
Region
| Japan |
Condition
Condition
Obesity, Non alcoholic fatty liver diseases (NAFLD)
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Clarify the effects of diet/exercise therapy on cytokines, extracellular vesicles (EVs) and metabolic parameters in obese children and patients with non -alcoholic fatty liver disease (NAFLD)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anthropometric data, body composition data and circulating EV number and component after receiving diet and exercise therapy,
Key secondary outcomes
Adipokines, myokines and hepatokines, lipid and glucose metabolism markers, and liver and kidney function markers after diet and exercise therapy.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Restriction of calorie intake and exercise for more than 6 months in obese children and patients with NAFLD.
Interventions/Control_2
Approximately 20 minutes of exercise using ergometer (once per tested person)
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Children (6 to 18 years) who receive the lecture for health and obtain informed consent at Mie National Hospital.
(2) Children (9 to 15 years) who attend the healthy camp and obtain informed consent at Mie National Hospital.
(3) Children (6 to 18 years) who received diet and exercise therapy and obtain informed consent at Mie National Hospital.
(4) Patients with NAFLD (equal or more than 18 years) who received diet and exercise therapy and obtain informed consent at Mie University Hospital.
(5) Healthy students of Mie University who perform exercise training routinely and obtain informed consent.
Key exclusion criteria
(1) Subjects who cannot declare their intention.
(2) Subjects whom doctors or researchers judged as inappropriate for the study.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Yoshinao |
| Middle name | |
| Last name | Kobayashi |
Organization
Mie University
Division name
Center for Physical and Mental Health
Zip code
514-8507
Address
1577 Kurimamachiya-cyo, Tsu, Mie 514-8507, Japan
TEL
059-231-5375
yoshinao@hac.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinao |
| Middle name | |
| Last name | Kobayashi |
Organization
Mie University
Division name
Center for Physical and Mental Health
Zip code
514-8507
Address
1577 Kurimamachiya-cyo, Tsu, Mie 514-8507, Japan
TEL
059-231-5375
Homepage URL
yoshinao@hac.mie-u.ac.jp
Sponsor or person
Institute
Center for Physical and Mental Health, Mie University
Institute
Department
Personal name
Funding Source
Organization
MEXT (Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Mie National Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethic Committee at Mie University Hospital
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
Tel
059-232-5045
s-kenkyu@mo.medic.mie-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 18 | Day |
Last modified on
| 2023 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035255
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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