UMIN-CTR Clinical Trial

Basic information
Public title	Diabetic Registry in Chikugo District
Acronym	Diabetic Registry in Chikugo District
Scientific Title	Diabetic Registry in Chikugo District
Scientific Title:Acronym	Diabetic Registry in Chikugo District
Region	Japan

Condition
Condition	Diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to establish a database for improving the treatment of diabetes.
Basic objectives2	Others
Basic objectives -Others	Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Distribution of various parameters related to glucose metabolism
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All patients, except those who did not wish to be enrolled in the study, were informed of the study by posting the details of the study on the website.
Key exclusion criteria	Patients who did not wish to be enrolled in this study
Target sample size	5000

Research contact person
Name of lead principal investigator	1st name Nobuhiko Middle name Last name Wada
Organization	Department of Internal Medicine, Kurume University School of Medicine
Division name	Division of Endocrinology and Metabolism
Zip code	830-0011
Address	67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL	0942-31-7563
Email	wada_nobuhiko@kurume-u.ac.jp

Public contact
Name of contact person	1st name Nobuhiko Middle name Last name Wada
Organization	Department of Internal Medicine, Kurume University School of Medicine
Division name	Division of Endocrinology and Metabolism
Zip code	830-0011
Address	67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL	0942-31-7563
Homepage URL
Email	wada_nobuhiko@kurume-u.ac.jp

Sponsor
Institute	Kurume University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Kurume University School of Medicine
Address	67 Asahi-machi, Kurume-shi, Fukuoka, Japan
Tel	0942-31-7563
Email	i_rinri@kurume-u.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	2022 Year 07 Month 26 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	783
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	2018 Year 05 Month 21 Day
Date of IRB	2018 Year 06 Month 29 Day
Anticipated trial start date	2018 Year 06 Month 29 Day
Last follow-up date	2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Items of medical information to be registered Medical history, diagnosis, age, age at diagnosis, sex, height, weight, abdominal circumference, grip strength, body composition, family history, medical history, lifestyle history (alcohol, tobacco, etc.), treatment details, blood tests (HbA1c, blood sugar including sugar metabolism related, liver function, kidney function, lipids, thyroid function, blood count, CRP, bone metabolism markers, etc.), urine test (occult blood, protein, albumin), fecal examination (occult blood, fat), bone mineral density, tendon reflexes, vibratory perception, gait speed, neck examination, etc. protein, albumin), fecal examination (occult blood, fat), bone mineral density, cognitive function evaluation, sleep evaluation, fundus examination, tendon reflexes, vibration perception, gait speed, carotid artery echo

Management information
Registered date	2022 Year 07 Month 26 Day
Last modified on	2022 Year 07 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055239