UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter clinical study on Blue Exercise for type2 diabetes patients
Title of the study (Brief title)	Blue Exercise Study
Region	Japan

Condition
Condition	Type2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of Blue Exercise, a new exercise program with a blue silicone band for type 2 diabetes patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in blood glucose with Blue Exercise performed 30-40 minutes after meal
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Blue Exercise is performed 30-40 minutes after test meal
Interventions/Control_2	Only test meal
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 Type 2 diabetes patients with educational hospitalization 2 Age 20y.o=< =<65y.o 3 HbA1c 7.0%=< =<10.0% 4 Patients who are na&iuml;ve or oral hypoglycemic agents 5 No severe progressive complications 6 Heart disease is denied by electrocardiogram, echocardiogram, etc. in the past 3 months 7 No other clinical trial within 30days 8 Signed informed consent obtained before any trial-related activities
Key exclusion criteria	1 Receiving insulin therapy 2 Receiving steroid therapy 3 Severe liver or renal dysfunction 4 Heart disease with no care 5 Severe infection or trauma, perioperative 6 History of gastrointestinal surgery 7 Pregnancy 8 Dementia 9 Pacemaker or ICD 10 Patients whose participation is deemed inappropriate at the discretion of the attending physician
Target sample size	15

Research contact person
Name of lead principal investigator	Yuzo Sato
Organization	Aichi Gakuin University
Division name	Health Science, Faculty of Psychological & Physical Science
Address	12 Araike, Iwasaki-cho, Nisshin 470-0195,Japan
TEL	056-173-1111
Email	satoy@dpc.agu.ac.jp

Public contact
Name of contact person	Genki Iwamura
Organization	Japan Association for Diabetes Education and Care
Division name	secretariat
Address	2-2-4 Kojimachi, Chiyoda-ku, Tokyo 102-0083, Japan
TEL	03-3514-1721
Homepage URL
Email	iwamura@nittokyo.or.jp

Sponsor
Institute	Japan Association for Diabetes Education and Care
Institute
Department

Funding Source
Organization	Japan Association for Diabetes Education and Care
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	2014 Year 03 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 08 Day
Anticipated trial start date	2013 Year 10 Month 31 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

Management information
Registered date	2014 Year 03 Month 05 Day
Last modified on	2018 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015501