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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030878
Receipt No. 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 2019/01/19

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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
Middle name
Last name Yoshinao Kobayashi
Organization Mie University
Division name Center for Physical and Mental Health
Zip code
Address 1577 Kurimamachiya-cyo, Tsu, Mie 514-8507, Japan
TEL 059-231-5375
Email yoshinao@hac.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinao Kobayashi
Organization Mie University
Division name Center for Physical and Mental Health
Zip code
Address 1577 Kurimamachiya-cyo, Tsu, Mie 514-8507, Japan
TEL 059-231-5375
Homepage URL
Email yoshinao@hac.mie-u.ac.jp

Sponsor
Institute Center for Physical and Mental Health, Mie University
Institute
Department

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
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

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
Anticipated trial start date
2018 Year 01 Month 19 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
2018 Year 01 Month 18 Day
Last modified on
2019 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035255

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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