UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation by self-administered survey regarding relationship between glylcaemic control and behavior over Angelica keiskei
Title of the study (Brief title)	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	Takuya Ishikawa
Organization	Oshima Medical Center
Division name	Internal Medicine
Address	3-2-9, Motomachi, Oshima, Tokyo, Japan
TEL	04992-2-2345
Email	tactash@yahoo.co.jp

Public contact
Name of contact person	Takuya Ishikawa
Organization	Oshima Medical Center
Division name	Internal Medicine
Address	3-2-9, Motomachi, Oshima, Tokyo, Japan
TEL	04992-2-2345
Homepage URL
Email	tactash@yahoo.co.jp

Sponsor
Institute	Oshima Medical Center
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035573