UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035069 |
|---|---|
| Receipt number | R000038386 |
| Scientific Title | Method to encourage consultation for people in Impaired Glucose Tolerance: a randomized control trial |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2021/06/03 09:45:37 |
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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
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
konda.manako.53v@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038386
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
