UMIN-CTR Clinical Trial

Basic information
Public title	Method to encourage consultation for people in Impaired Glucose Tolerance: a randomized control trial
Acronym	to go see doc trial
Scientific Title	Method to encourage consultation for people in Impaired Glucose Tolerance: a randomized control trial
Scientific Title:Acronym	to go see doc trial
Region	Japan

Condition
Condition	Impaired Glucose Tolerance
Classification by specialty	Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to prevent diabetes mellitus, encourage people who are pointed out Impaired Glucose Tolerance at a comprehensive medical examination to go life style related consultation in early term. 1) Develop a decision aid to encourage people going consultation. 2) Confirm the efficacy of the decision aid.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A rate of people who go for medical consultation related to Impaired Glucose Tolerance.
Key secondary outcomes	(1) A rate of people who get worse of their Impaired Glucose Tolerance. (2) Changing in blood sugar. (3) Changing in HbA1c.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Intervention: new method of explanation
Interventions/Control_2	Control: conventional method of explanation
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	(1) 20-75y-o at the point of the comprehensive medical check. (2) Correspond one of followings. a) HbA1c: 6.0-6.4% b) Fasting blood sugar: 110-125 mg/dL c) Blood sugar after two hours of oral glucose tolerance test: 140-199 mg/dL
Key exclusion criteria	(1) Undergoing treatment of Diabetes mellitus at the point of the comprehensive medical check. (2) Not be proved the results of the comprehensive medical check in the test day. (3) Need informed assent. (4) Not agree with participating in the study.
Target sample size	490

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Kobayashi
Organization	Kyoto University
Division name	Agency for Health, Safety and Environment
Zip code	606-8501
Address	Yoshidahon-machi, Sakyo-ku, Kyoto
TEL	075-753-2415
Email	kobayashi.daisuke.2e@kyoto-u.ac.jp

Public contact
Name of contact person	1st name Manako Middle name Last name Konda
Organization	Kyoto University
Division name	School of Public Health Department of Preventive Services
Zip code	606-8501
Address	Yoshidahon-machi, Sakyo-ku, Kyoto
TEL	075-753-2431
Homepage URL
Email	konda.manako.53v@st.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
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	Kyoto University Graduate School and Faculty of Medicine, Kyoto University Hospital Ethics Committee
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-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	2019 Year 02 Month 01 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	No longer recruiting
Date of protocol fixation	2018 Year 09 Month 21 Day
Date of IRB	2018 Year 11 Month 29 Day
Anticipated trial start date	2019 Year 05 Month 17 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 29 Day
Last modified on	2021 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038386