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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036076
Receipt No. R000041102
Scientific Title Thicken liquid can influence of the effect of anti-diabetic medicine
Date of disclosure of the study information 2019/03/04
Last modified on 2019/03/04

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Basic information
Public title Thicken liquid can influence of the effect of anti-diabetic medicine
Acronym Thicken liquid and anti-diabetic medicine
Scientific Title Thicken liquid can influence of the effect of anti-diabetic medicine
Scientific Title:Acronym Thicken liquid and anti-diabetic medicine
Region
Japan

Condition
Condition diabetic patients with dysphagia
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Geriatrics
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to investigate if thicken liquid influence the effect of anti-diabetic medicine.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes blood glucose level
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 the change in something to drink with taking medicine from thicker liquid to jelly.
Interventions/Control_2
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Type-2 diabetic patients with dysphagia
Key exclusion criteria Not stable general condition
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruka Tohara
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology,
Zip code
Address 1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN
TEL 03-5803-5562
Email haruka-t@rd5.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Hara
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology,
Zip code
Address 1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN
TEL 03-5803-5562
Homepage URL
Email koji119831031@gmail.com

Sponsor
Institute Tokyo medical dental university
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2019 Year 03 Month 04 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 01 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
2019 Year 03 Month 04 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041102

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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