UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031141 |
|---|---|
| Receipt number | R000035573 |
| Scientific Title | Investigation by self-administered survey regarding relationship between glylcaemic control and behavior over Angelica keiskei |
| Date of disclosure of the study information | 2018/02/05 |
| Last modified on | 2018/08/17 17:53:15 |
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Basic information
Public title
Investigation by self-administered survey regarding relationship between glylcaemic control and behavior over Angelica keiskei
Acronym
Ashitaba Study
Scientific Title
Investigation by self-administered survey regarding relationship between glylcaemic control and behavior over Angelica keiskei
Scientific Title:Acronym
Ashitaba Study
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate a relationship between glycaemic control and behavior over Angelica keiskei, in type 2 diabetes patients living in Izu Oshima island.
Basic objectives2
Others
Basic objectives -Others
To investigate a relationship between lifestyle habit and behavior over Angelica keiskei, in type 2 diabetes patients living in Izu Oshima island.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between glycemic control and behavior over Angelica keiskei
Key secondary outcomes
Relationship between lifestyle habit and behavior over Angelica keiskei
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Adults who are 20 years or older and 90 years or younger
2. Type 2 diabetes patients
3. HbA1c 6.0% to 10.0%
4. Patients below BMI 35kg/m^2
5. Patients who can understand consent suffiently and having the agreement regarding participation in this examination
Key exclusion criteria
1. Patients who are diagnosed type 2 diabetes within 6 months
2. Patients who has a record of Anti-GAD Antibody positive
3. A pregnant woman or a woman who may be pregnant
4. Patients who will be considered inappropriate by an attendant physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuya Ishikawa |
Organization
Oshima Medical Center
Division name
Internal Medicine
Zip code
Address
3-2-9, Motomachi, Oshima, Tokyo, Japan
TEL
04992-2-2345
tactash@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Ishikawa |
Organization
Oshima Medical Center
Division name
Internal Medicine
Zip code
Address
3-2-9, Motomachi, Oshima, Tokyo, Japan
TEL
04992-2-2345
Homepage URL
tactash@yahoo.co.jp
Sponsor or person
Institute
Oshima Medical Center
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 02 | Month | 05 | 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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
unpublished
Management information
Registered date
| 2018 | Year | 02 | Month | 05 | Day |
Last modified on
| 2018 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035573
