UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036076 |
|---|---|
| Receipt number | 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 15:18:31 |
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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
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
koji119831031@gmail.com
Sponsor or person
Institute
Tokyo medical dental university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041102
