UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038658
Receipt number R000043920
Scientific Title Effects of Work out on Glucose Homeostasis
Date of disclosure of the study information 2020/01/10
Last modified on 2019/11/11 14:27:04

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Basic information

Public title

Effects of Work out on Glucose Homeostasis

Acronym

WORKG-pilot

Scientific Title

Effects of Work out on Glucose Homeostasis

Scientific Title:Acronym

WORKG-pilot

Region

Japan


Condition

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To test the effects of work out on glucose homeostasis and blood levels of glucose and other markers

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Changes of muscle volume and blood glucose control

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Work out for 24 weeks

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Individuals who have been diagnosed as type 2 diabetes and continue their therapies adequately, in addition, who are able to join a 24 week course, twice per week, at a work out gym, and 3 exams in a health check lab in Tokyo.

Key exclusion criteria

Diabetic patients with nephrological disorder grade 3 or more, retinopathy grade A2 or worse, having neuropathy, or having experience of stroke or heart attack within 6 month. Individuals who are considered not to participate in this study will be also excluded.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Masumi
Middle name
Last name Ai

Organization

Tokyo Medical and Dental University

Division name

Department of Insured Medical Care Management

Zip code

1138519

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

0338136111

Email

ai.vasc@tmd.ac.jp


Public contact

Name of contact person

1st name Masumi
Middle name
Last name Ai

Organization

Tokyo Medical and Dental University

Division name

Department of Insured Medical Care Management

Zip code

1138519

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

0338136111

Homepage URL


Email

ai.vasc@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

RIZAP Co. Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB, Medical school, Tokyo Medical and Dental University

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

Tel

0338136111

Email

info.bec@tmd.ac.jp


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

2020 Year 01 Month 10 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

Preinitiation

Date of protocol fixation

2019 Year 11 Month 12 Day

Date of IRB


Anticipated trial start date

2020 Year 01 Month 10 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 11 Month 21 Day

Last modified on

2019 Year 11 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043920


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name