UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018694
Receipt number R000021287
Scientific Title Comparison of the Effects of Using Activity Monitors and Pedometers in Patients with Type 2 Diabetes Completing Therapeutic Exercise to Reduce Blood Glucose
Date of disclosure of the study information 2015/08/17
Last modified on 2015/08/24 11:21:36

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Basic information

Public title

Comparison of the Effects of Using Activity Monitors and Pedometers in Patients with Type 2 Diabetes Completing Therapeutic Exercise to Reduce Blood Glucose

Acronym

Study of the Effects of Using Activity Monitors

Scientific Title

Comparison of the Effects of Using Activity Monitors and Pedometers in Patients with Type 2 Diabetes Completing Therapeutic Exercise to Reduce Blood Glucose

Scientific Title:Acronym

Study of the Effects of Using Activity Monitors

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The following two points will be investigated by using activity monitors that display the exercise intensity in addition to the number of steps during exercise therapy for patients with type 2 diabetes.

1.Whether exercise performed with an awareness of the intensity leads to improvement of blood glucose control (decreases in HbA1c).

2.Whether the possession of an intensity-monitoring device changes the awareness of the patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in HbA1c of 2 months after the start (interim analysis) and 6 months (final analysis).

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

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

Activity monitor group is lent at the time of first examination, and the procedure for the exercise and how to make records are explained.
Activity monitor group is required to bring the record table at the time of first examination every month, make reports, and receive instructions about exercises.

Interventions/Control_2

Pedometer group is lent at the time of first examination, and the procedure for the exercise and how to make records are explained.
Pedometer group is required to bring the record table at the time of first examination every month, make reports, and receive instructions about exercises.

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

Type 2 Diabetes
Patients with consent ability in 20 years of age or older.

Key exclusion criteria

Patients judged by the investigator to be ineligible for some other reason

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masao Toyoda

Organization

Department of Internal Medicine, Tokai University School of Medicine

Division name

Division of Nephrology, Endocrinology and Metabolism

Zip code


Address

143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN

TEL

0563-93-1121

Email

m-toyoda@is.icc.u-tokai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Wakana Miura

Organization

Department of Internal Medicine, Tokai University School of Medicine

Division name

Division of Nephrology, Endocrinology and Metabolism

Zip code


Address

143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN

TEL

0563-93-1121

Homepage URL


Email

happy0897@gmail.com


Sponsor or person

Institute

Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine

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

2015 Year 08 Month 17 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2012 Year 01 Month 11 Day

Date of IRB


Anticipated trial start date

2012 Year 02 Month 28 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

2015 Year 08 Month 17 Day

Last modified on

2015 Year 08 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021287


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name