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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020249
Receipt No. 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

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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
Email 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
Email eritake122@hotmail.com

Sponsor
Institute Kitasato university Kitasato institute hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023379

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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