UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020249 |
|---|---|
| Receipt number | R000023379 |
| Scientific Title | Effect of low-intensity resistance training with slow movement and tonic force generation (LST) on glucose tolerance in type 2 DM. |
| Date of disclosure of the study information | 2015/12/17 |
| Last modified on | 2015/12/17 13:10:48 |
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Basic information
Public title
Effect of low-intensity resistance training with slow movement and tonic force generation (LST) on glucose tolerance in type 2 DM.
Acronym
Effect of muscular training on glucose tolerance in type 2 DM.
Scientific Title
Effect of low-intensity resistance training with slow movement and tonic force generation (LST) on glucose tolerance in type 2 DM.
Scientific Title:Acronym
Effect of muscular training on glucose tolerance in type 2 DM.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate acute and long-term effects of LST on glucose tolerance in type 2 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
Fasting blood glucose
Muscle strength of lower limbs
Body composition
Muscle thickness of front portion of the thigh
Body weight
Blood hormon concentration: insulin, noradrenalin, adrenalin, cortisol, growth hormon
Blood lactate concentration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Patiensts receive standard medicine and nutrition counseling.
Interventions/Control_2
Patients receive standard medicine and nutrition counseling, and perform LST training twice a week during 4-months.
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Type 2 diabetes outpatients of Kitasato institute hospital
2 HbA1c 6.5%=< =<8.0%
3 Inexperienced persons of a resistance training
4 Patients whose participation is deemed appropriate at the discretion of the attending physician
5 Patients who give signed informed consent to participate in this study
Key exclusion criteria
1 Patients with history of stroke in the past 3 months
2 Patients with history of coronary artery disease in the past 1 year
3 Patients with severe osteoarthritis
4 Patients with history of increase of CPK in the past 1 year
5 Patients whose participation is deemed inappropriate at the discretion of the attending physician
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naokata Ishii |
Organization
Department of Life Sciences, Graduate School of Arts and Sciences, The University of Tokyo
Division name
Laboratory of Sports Sciences
Zip code
Address
3-8-1 Komaba, Meguro-ku, Tokyo, Japan
TEL
03-5454-6870
ishii@idaten.c.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eri Takenami |
Organization
Department of Life Sciences, Graduate School of Arts and Sciences, The University of Tokyo
Division name
Laboratory of Sports Sciences
Zip code
Address
3-8-1 Komaba, Meguro-ku, Tokyo, Japan
TEL
03-5454-6870
Homepage URL
eritake122@hotmail.com
Sponsor or person
Institute
Kitasato university Kitasato institute hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato university Kitasato institute hospital
Organization
Division
Category of Funding Organization
Self funding
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
北里大学北里研究所病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 17 | 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
| 2012 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 10 | 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
| 2015 | Year | 12 | Month | 17 | Day |
Last modified on
| 2015 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023379
| 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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