UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022454 |
|---|---|
| Receipt number | R000020678 |
| Scientific Title | Dietary intervention for type 2 diabetes in clinics |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2020/05/29 22:49:53 |
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Basic information
Public title
Dietary intervention for type 2 diabetes in clinics
Acronym
Dietary intervention for type 2 diabetes in clinics
Scientific Title
Dietary intervention for type 2 diabetes in clinics
Scientific Title:Acronym
Dietary intervention for type 2 diabetes in clinics
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the effective methods of dietary habit education for type 2 diabetes in clinics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c and BMI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Newsletter twice per month for 5 months
Interventions/Control_2
Standard of care
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with written informed consent.
2) Type of practice: outpatient department.
Key exclusion criteria
1) Patients who did not agree with joining this study.
2) Patients who are ineligible for some other reason judged by attending physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Michiaki |
| Middle name | |
| Last name | Fukui |
Organization
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name
Department of Endocrinology and Metabolism
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku Kyoto Japan
TEL
+81-75-251-5505
michiaki@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Wada |
| Middle name | |
| Last name | Sayori |
Organization
Kyoto Prefectural University, Graduate School of Life and Environmental Sciences
Division name
Food Science and Nutritional Health
Zip code
606-8522
Address
1-5 Shimogamo-Hangi-cho Sayo-ku Kyoto Japan
TEL
+81-75-801-5484
Homepage URL
poisson@kpu.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University, Graduate School of Life and Environmental Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoto Prefectural University, Graduate School of Life and Environmental Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine, Clinical Research Review Board
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
Tel
+81-75-251-5337
rinri@koto.kpu-m.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
| 2016 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 30 | 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
| 2016 | Year | 05 | Month | 25 | Day |
Last modified on
| 2020 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020678
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
