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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018694
Receipt No. R000021287
Scientific Title Comparison of the Effects of Using Activity Monitors and Pedometers in Patients with Type 2 Diabetes Completing Therapeutic Exercise to Reduce Blood Glucose
Date of disclosure of the study information 2015/08/17
Last modified on 2015/08/24

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Basic information
Public title Comparison of the Effects of Using Activity Monitors and Pedometers in Patients with Type 2 Diabetes Completing Therapeutic Exercise to Reduce Blood Glucose
Acronym Study of the Effects of Using Activity Monitors
Scientific Title Comparison of the Effects of Using Activity Monitors and Pedometers in Patients with Type 2 Diabetes Completing Therapeutic Exercise to Reduce Blood Glucose
Scientific Title:Acronym Study of the Effects of Using Activity Monitors
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The following two points will be investigated by using activity monitors that display the exercise intensity in addition to the number of steps during exercise therapy for patients with type 2 diabetes.

1.Whether exercise performed with an awareness of the intensity leads to improvement of blood glucose control (decreases in HbA1c).

2.Whether the possession of an intensity-monitoring device changes the awareness of the patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in HbA1c of 2 months after the start (interim analysis) and 6 months (final analysis).
Key secondary outcomes

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 Activity monitor group is lent at the time of first examination, and the procedure for the exercise and how to make records are explained.
Activity monitor group is required to bring the record table at the time of first examination every month, make reports, and receive instructions about exercises.
Interventions/Control_2 Pedometer group is lent at the time of first examination, and the procedure for the exercise and how to make records are explained.
Pedometer group is required to bring the record table at the time of first examination every month, make reports, and receive instructions about exercises.
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
90 years-old >
Gender Male and Female
Key inclusion criteria Type 2 Diabetes
Patients with consent ability in 20 years of age or older.
Key exclusion criteria Patients judged by the investigator to be ineligible for some other reason
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masao Toyoda
Organization Department of Internal Medicine, Tokai University School of Medicine
Division name Division of Nephrology, Endocrinology and Metabolism
Zip code
Address 143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL 0563-93-1121
Email m-toyoda@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Wakana Miura
Organization Department of Internal Medicine, Tokai University School of Medicine
Division name Division of Nephrology, Endocrinology and Metabolism
Zip code
Address 143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL 0563-93-1121
Homepage URL
Email happy0897@gmail.com

Sponsor
Institute Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine
Institute
Department

Funding Source
Organization Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine
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

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 17 Day

Related information
URL releasing protocol
Publication of results Partially published

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 01 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 28 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 08 Month 17 Day
Last modified on
2015 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021287

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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