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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025629
Receipt No. R000029479
Scientific Title Support of diabetes Mellitus patient daily life -Patient Lifestyle is improved by community pharmacistS-
Date of disclosure of the study information 2017/01/12
Last modified on 2019/07/16

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Basic information
Public title Support of diabetes Mellitus patient daily life
-Patient Lifestyle is improved by community pharmacistS-
Acronym Support of diabetes Mellitus patient daily life
-Patient Lifestyle is improved by community pharmacistS-
Scientific Title Support of diabetes Mellitus patient daily life
-Patient Lifestyle is improved by community pharmacistS-
Scientific Title:Acronym Support of diabetes Mellitus patient daily life
-Patient Lifestyle is improved by community pharmacistS-
Region
Japan

Condition
Condition Diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate that the activity mass of diabetic patients is affected by lifestyle guidance by community pharmacists.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes activity mass (consumption energy, count of steps, time of moderately intense walking)
Key secondary outcomes PAID, HbA1c, TC, HDL-C, TG, weight, blood pressure, abdominal circumference, boundary length of lower leg, rate of antidiabetes drugs, rate of antihypertensive drugs use, rate of antihyperlipidemic drug use, fasting glucose level, AST, ALT, r-GTP, relationship between PAID and activity mass, relationship between HbA1c and activity mass

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Using only Mediwalk
Interventions/Control_2 Using Mediwalk and Smiledatavision
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) HbA1c >=9 %
2) Type 2 diabetes (no restriction of prescription medication)
3) Possible to prescribed blood sampling in hospitals
4) 20-years-old and above
5) Individuals capable of giving voluntary, informed consent in writing
6) Permission of sub-investigator (doctor)
Key exclusion criteria ) Using of walking intensity monitor over the past 3 months
2) Exercise contraindication
3) Participating in another clinical study
4) Pregnant or possibility of pregnancy
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Ryo
Middle name
Last name Matsushita
Organization Kanazawa University
Division name Faculty of Pharmacy, Institute of Medical, Pharmaceutical Sciences
Zip code 920-1192
Address Kanazawa
TEL 0762344405
Email matusita@p.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name Ryo
Middle name
Last name Matsushita
Organization Kanazawa University
Division name Faculty of Pharmacy, Institute of Medical, Pharmaceutical Sciences
Zip code 920-1192
Address Kanazawa
TEL 0762344405
Homepage URL
Email matusita@p.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization None
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 Kanazawa University, Medical Institutional Review Board
Address Takara-machi, 13-1, Kanazawa, Ishikawa
Tel 076-265-2103
Email t-isomu@adm.kanazawa-u.ac.jp

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
2017 Year 01 Month 12 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 Enrolling by invitation
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
2016 Year 07 Month 20 Day
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 11 Day
Last modified on
2019 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029479

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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