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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004439 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Metabolic syndrome and type 2 diabetes mellitus | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | School of Medicine, Keio University | ||||||
Division name | Institute for Integrated Sports Medicine | ||||||
Zip code | |||||||
Address | 35 Shinanomachi, Shinjuku-ku, Tokyo160-8582, Japan | ||||||
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Public contact | |||||||
Name of contact person |
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Organization | School of Medicine, Keio University | ||||||
Division name | Institute for Integrated Sports Medicine | ||||||
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TEL | |||||||
Homepage URL | |||||||
azuma@sc.itc.keio.ac.jp |
Sponsor | |
Institute | Institute for Integrated Sports Medicine, School of Medicine, Keio University |
Institute | |
Department |
Funding Source | |
Organization | Japan Society for the Promotion Science |
Organization | |
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IRB Contact (For public release) | |
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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 |
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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 | |
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Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005308 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |