UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Thicken liquid can influence of the effect of anti-diabetic medicine
Title of the study (Brief title)	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	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,
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	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,
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 04 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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