UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The impact of marital and socioeconomic status on the risk of diabetic complications :cross-sectional study
Title of the study (Brief title)	The impact of marital and socioeconomic status on the risk of diabetic complications :cross-sectional study
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the relationship between marital status, public welfare assistance and glycemic control, complications, furthermore assess the combination risk.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diabetic complications( neuropathy, retinopathy, nephropathy) at admission
Key secondary outcomes	HbA1c at admission

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	diabetic patients admitted to Saiseikai yokohamashi nanbu hospital for their diabetic care
Key exclusion criteria	none
Target sample size	300

Research contact person
Name of lead principal investigator	Yuya Takano
Organization	Saiseikai Yokohamashi Nanbu Hospital
Division name	Department of Diabetes and Endocrinology
Address	3-2-10, Konandai Konan-ku , Yokohama City, kanagawa 234-0054, Japan
TEL	0458321111
Email	taka1018083@yahoo.co.jp

Public contact
Name of contact person	Yuya Takano
Organization	Saiseikai Yokohamashi Nanbu Hospital
Division name	Department of Diabetes and Endocrinology
Address	3-2-10, Konandai Konan-ku , Yokohama City, kanagawa 234-0054, Japan
TEL	0458321111
Homepage URL
Email	taka1018083@yahoo.co.jp

Sponsor
Institute	Saiseikai Yokohamashi Nanbu Hospital
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)

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	2017 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 09 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	We clarify that singles and low income people are at high risk in the progress of diabetic complications.

Management information
Registered date	2017 Year 07 Month 26 Day
Last modified on	2018 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032295