UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004591
Receipt number R000005483
Scientific Title Development of a intensified diabetes intervention program at work places
Date of disclosure of the study information 2011/12/31
Last modified on 2016/11/25 12:22:23

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Basic information

Public title

Development of a intensified diabetes intervention program at work places

Acronym

Development of a intensified diabetes intervention program at work places

Scientific Title

Development of a intensified diabetes intervention program at work places

Scientific Title:Acronym

Development of a intensified diabetes intervention program at work places

Region

Japan


Condition

Condition

Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We intend to develop an intensified intervention program for diabetic employees to modify their life style, which is easily executable and efficient at work places that do not have thier own medical facilities.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

HbA1c
calorie intake
exercise level

Key secondary outcomes

anti-diabetic drug usage


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-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

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

1. Lecture regarding life style modifycation (at the time of enrollment)
2. Monthly 30 min interview
3. HbA1c measurement and physical examination at each interview (Data feedbacked to the subjects)

Interventions/Control_2

Lecture regarding life style modifycation (at the time of enrollment)

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Diabetic patients in entities with employees participating in a study, entitled 'A cohort study to reveal factors that contribute to the onset of diabetes/metabolic syndrome through a development of insulin resistance'
Diabetic patients are defined as individuals with FBS <= 126 mg/dl or HbA1c <= 6.5%, or individuals treated with anti-diabetic medication due to a diagnosis of diabetes.
Out of diabetic patients described above, individuals who 1. give written consents for participation, 2. are male or female, 3. aged betweem 20 and 65 are eligible.

Key exclusion criteria

Individuals without written consents

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Funaki

Organization

Tokushima University Hospital

Division name

Clinical Research Center for Diabetes

Zip code


Address

2-50-1 Kuramoto-cho Tokushima Japan

TEL

088-633-9679

Email

m-funaki@clin.med.tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Makoto Funaki

Organization

Tokushima University Hospital

Division name

Clinical Research Center for Diabetes

Zip code


Address

2-50-1 Kuramoto-cho Tokushima Japan

TEL

088-633-9679

Homepage URL


Email

m-funaki@clin.med.tokushima-u.ac.jp


Sponsor or person

Institute

Clinical Research Center for Diabetes
Tokushima University Hospital

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Department of Medical Treatment Recovery Care Nursing
Institute of Health Biosciences
University of Tokushima Graduate School

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

徳島大学病院(徳島県)


Other administrative information

Date of disclosure of the study information

2011 Year 12 Month 31 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

2010 Year 11 Month 15 Day

Date of IRB


Anticipated trial start date

2011 Year 02 Month 01 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

2010 Year 11 Month 19 Day

Last modified on

2016 Year 11 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005483


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name