UMIN-CTR Clinical Trial

Basic information
Public title	Research for new factors associated with diabetic complications
Acronym	Research for new factors associated with diabetic complications
Scientific Title	Research for new factors associated with diabetic complications
Scientific Title:Acronym	Research for new factors associated with diabetic complications
Region	Japan

Condition
Condition	Diabetes
Classification by specialty	Medicine in general Gastroenterology Cardiology Endocrinology and Metabolism Nephrology Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to search for new factors associated with diabetic complications.
Basic objectives2	Others
Basic objectives -Others	cross-sectional and retrospective study
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Associations between clinical characteristics and both development and progression of diabetic complications.
Key secondary outcomes	Associations between clinical characteristics and both pathophysiology and severity of diabetic complications.

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients treated with diabetes 2. Patients aged 20 years or older
Key exclusion criteria	1. Patients less that 20 years 2. Patients refusing the use of own clinical data 3. Patients who the principal investigator determined to be unsuitable for study
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Watanabe Middle name Last name Kentaro
Organization	Nihon University School of Medicine
Division name	Division of Diabetes and Metabolic Diseases, Department of Internal Medicine
Zip code	1738610
Address	30-1 Oyaguchi-kamicho, Itbashi-ku
TEL	0339728111
Email	watanabe.kentaro@nihon-u.ac.jp

Public contact
Name of contact person	1st name Watanabe Middle name Last name Kentaro
Organization	Nihon University School of Medicine
Division name	Division of Diabetes and Metabolic Diseases, Department of Internal Medicine
Zip code	1738610
Address	30-1 Oyaguchi-kamicho, Itabashi-ku
TEL	0339728111
Homepage URL
Email	watanabe.kentaro@nihon-u.ac.jp

Sponsor
Institute	Division of Diabetes and Metabolic Diseases, Department of Internal Medicine, Nihon University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nihon University Itabashi Hospital Clinical Research Judging Committee
Address	30-1 Oyaguchi-kamicho, Itbashi-ku
Tel	0339728111
Email	watanabe.kentaro@nihon-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	日本大学医学部附属板橋病院

Other administrative information
Date of disclosure of the study information	2020 Year 08 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
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	Enrolling by invitation
Date of protocol fixation	2018 Year 08 Month 24 Day
Date of IRB	2018 Year 08 Month 24 Day
Anticipated trial start date	2018 Year 08 Month 24 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	Interim analysis is performed

Management information
Registered date	2020 Year 08 Month 26 Day
Last modified on	2020 Year 08 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047457