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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021777
Receipt No. R000024906
Scientific Title Exercise adaptation and metabolic disorders
Date of disclosure of the study information 2016/04/04
Last modified on 2016/04/04

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Basic information
Public title Exercise adaptation and metabolic disorders
Acronym Exercise adaptation and metabolic disorders
Scientific Title Exercise adaptation and metabolic disorders
Scientific Title:Acronym Exercise adaptation and metabolic disorders
Region
Japan

Condition
Condition Obesity, Hypertension, Diabetes, Dyslipidemia, Metabolic syndrome
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate the effects of exercise training and diet on metabolic disorders.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body weight. After 3 months of the intervention
Key secondary outcomes Visceral fat, Body composition, Blood pressure, Glucose metabolism, Blood lipids, Cardio-respiratory fitness, Energy metabolism. After 3 months of the intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Exercise group
300 min/wk in moderate intensity
12 weeks intervention
Interventions/Control_2 Diet group
Ideal body weight multiplied by 25kcal/day
12 weeks intervention
Interventions/Control_3 Intervention 1+2
12 weeks intervention
Interventions/Control_4 Control group
12 weeks intervention
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Adults with risks for metabolic syndrome.
Key exclusion criteria 1) Type 1 diabetes
2) Secondary diabetes
3) Malfunction of glucose metabolism
4) Acute infectious disease
5) Proliferating retinopathy or fundus hemorrhage
6) liver or kidney disease
7) Ischemic heart disease
8) Severe bone disease
9) Diabetic gangrene
10) Autonomy neuropathic disorder
11) Doctor's instructions
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Tanaka
Organization Fukuoka University
Division name Fuculty of sports science
Zip code
Address 8-19-1 Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, Japan
TEL 092-871-6631
Email htanaka@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Tanaka
Organization Fukuoka University
Division name Fuculty of sports science
Zip code
Address 8-19-1 Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, Japan
TEL 092-871-6631
Homepage URL
Email htanaka@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University
Institute
Department

Funding Source
Organization The ministry of Education, Culture, Sports, Science and Technology in Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 04 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 Completed
Date of protocol fixation
2006 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 01 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
2016 Year 04 Month 04 Day
Last modified on
2016 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024906

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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