UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004439 |
|---|---|
| Receipt number | R000005308 |
| Scientific Title | The effect of the two exercise regimens on body composition in type 2 DM as a part of metabolic syndrome |
| Date of disclosure of the study information | 2010/10/25 |
| Last modified on | 2015/04/25 19:06:52 |
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Basic information
Public title
The effect of the two exercise regimens on body composition in type 2 DM as a part of metabolic syndrome
Acronym
The effect of exercise on body composition in type 2 DM and metabolic syndrome
Scientific Title
The effect of the two exercise regimens on body composition in type 2 DM as a part of metabolic syndrome
Scientific Title:Acronym
The effect of exercise on body composition in type 2 DM and metabolic syndrome
Region
| Japan |
Condition
Condition
Metabolic syndrome and type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To see whether long-term training with relatively high intensity and long bout, may effectively affect energy balance within muscle, and have additive favorable changes in body composition, independent of weight loss.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition
Key secondary outcomes
Physical activity
Body weight
Plasama glucose concentration
HbA1c
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
to receive relatively high-intensity and long bout exercise
Interventions/Control_2
to receive advices to promote physical activity
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 DM as a part of metabolic syndrome
Key exclusion criteria
Subjects with disability for exercise
Already physically active subjects
Subjects with low insulin secretory capacity
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Azuma |
Organization
School of Medicine, Keio University
Division name
Institute for Integrated Sports Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo160-8582, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
School of Medicine, Keio University
Division name
Institute for Integrated Sports Medicine
Zip code
Address
TEL
Homepage URL
azuma@sc.itc.keio.ac.jp
Sponsor or person
Institute
Institute for Integrated Sports Medicine, School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion Science
Organization
Division
Category of Funding Organization
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
| 2010 | Year | 10 | Month | 25 | 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
| 2010 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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
| 2010 | Year | 10 | Month | 25 | Day |
Last modified on
| 2015 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005308
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
