UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021777 |
|---|---|
| Receipt number | R000024906 |
| Scientific Title | Exercise adaptation and metabolic disorders |
| Date of disclosure of the study information | 2016/04/04 |
| Last modified on | 2016/04/04 21:14:09 |
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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
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
htanaka@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024906
