UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013342
Receipt number R000015501
Scientific Title Multicenter clinical study on Blue Exercise for type2 diabetes patients
Date of disclosure of the study information 2014/03/05
Last modified on 2018/09/07 11:54:33

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Multicenter clinical study on Blue Exercise for type2 diabetes patients

Acronym

Blue Exercise Study

Scientific Title

Multicenter clinical study on Blue Exercise for type2 diabetes patients

Scientific Title:Acronym

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

1st name
Middle name
Last name Yuzo Sato

Organization

Aichi Gakuin University

Division name

Health Science, Faculty of Psychological & Physical Science

Zip code


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

1st name
Middle name
Last name Genki Iwamura

Organization

Japan Association for Diabetes Education and Care

Division name

secretariat

Zip code


Address

2-2-4 Kojimachi, Chiyoda-ku, Tokyo 102-0083, Japan

TEL

03-3514-1721

Homepage URL


Email

iwamura@nittokyo.or.jp


Sponsor or person

Institute

Japan Association for Diabetes Education and Care

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

2013 Year 10 Month 08 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015501


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name