UMIN-CTR Clinical Trial

Basic information
Public title	Establishment and analysis of Diabetes Registry in Chikugo
Acronym	Establishment and analysis of Diabetes Registry in Chikugo
Scientific Title	Establishment and analysis of Diabetes Registry in Chikugo
Scientific Title:Acronym	Establishment and analysis of Diabetes Registry in Chikugo
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 of patients with diabetes mellitus and to identify effective diabetes treatments.
Basic objectives2	Others
Basic objectives -Others	To elucidate the specific and effective target to help treating the patients with DM in this region.
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	The research subjects must be registered in the "Registry of Diabetes Patients in Chikugo Area" (Kurume University IRB, Research No. 18053) by attending or being hospitalized between June 2018 and June 2019 at the Department of Endocrinology and Metabolism, Kurume University, and at the collaborating research institutions.
Key exclusion criteria	Research subjects who have requested to opt out of the study. Those who do not agree to participate in this study.
Target sample size	783

Research contact person
Name of lead principal investigator	1st name Mizuki Middle name Last name Gobaru
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	goubaru_miduki@med.kurume-u.ac.jp

Public contact
Name of contact person	1st name Mizuki Middle name Last name Gobaru
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	goubaru_miduki@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University
Institute
Department

Funding Source
Organization	self-financing
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	No longer recruiting
Date of protocol fixation	2018 Year 05 Month 21 Day
Date of IRB	2022 Year 06 Month 06 Day
Anticipated trial start date	2018 Year 06 Month 29 Day
Last follow-up date	2027 Year 04 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=R000055242