UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of a intensified diabetes intervention program at work places
Title of the study (Brief title)	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	Makoto Funaki
Organization	Tokushima University Hospital
Division name	Clinical Research Center for Diabetes
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	Makoto Funaki
Organization	Tokushima University Hospital
Division name	Clinical Research Center for Diabetes
Address	2-50-1 Kuramoto-cho Tokushima Japan
TEL	088-633-9679
Homepage URL
Email	m-funaki@clin.med.tokushima-u.ac.jp

Sponsor
Institute	Clinical Research Center for Diabetes Tokushima University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2010 Year 11 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005483