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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018591
Receipt No. R000021519
Scientific Title Relationships between the duration of illness and the current status of diabetes in elderly patients with type 2 diabetes mellitus
Date of disclosure of the study information 2015/08/07
Last modified on 2015/08/07

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Basic information
Public title Relationships between the duration of illness and the current status of diabetes in elderly patients with type 2 diabetes mellitus
Acronym Relationships between the duration of illness and the current status of diabetes in elderly patients with type 2 diabetes mellitus
Scientific Title Relationships between the duration of illness and the current status of diabetes in elderly patients with type 2 diabetes mellitus
Scientific Title:Acronym Relationships between the duration of illness and the current status of diabetes in elderly patients with type 2 diabetes mellitus
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study was to clarify the relationships between the duration of diabetes and the current statuses of diabetes in elderly (= or > 65 years) patients with type 2 diabetes.
Basic objectives2 Others
Basic objectives -Others The aim of this study was to clarify the relationships between the duration of diabetes and the current statuses of diabetes in elderly (= or > 65 years) patients with type 2 diabetes.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Diabetic vascular complications
Key secondary outcomes Patients' age, gender, duration of diabetes, therapeutic methods and laboratory data including HbA1c

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 A population of 2,130 patients with type 2 diabetes mellitus who underwent consecutive treatments in the Department of Diabetes, Metabolism and Kidney Disease of Edogawa Hospital, Tokyo, Japan between 2009 and 2012 were screened for this study. In order to evaluate sufficiently the clinical characteristics of the patients, 401 subjects whose treatment periods in our department were less than six months and 293 subjects whose duration of diabetes was unclear based on their medical records were excluded from the current study. Thus, the associations between the duration of diabetes and the other clinical characteristics of the patients were examined in 1,436 subjects in the present cross-sectional study.
Key exclusion criteria Subjects whose treatment periods in our department were less than six months and subjects whose duration of diabetes was unclear
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Ito
Organization Edogawa Hospital
Division name Department of Diabetes, Metabolism and Kidney Disease
Zip code
Address 2-24-18, Higashikoiwa, Edogawa-ku, Tokyo, 133-0052
TEL 03-3673-1221
Email ito@edogawa.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Ito
Organization Edogawa Hospital
Division name Department of Diabetes, Metabolism and Kidney Disease
Zip code
Address 2-24-18, Higashikoiwa, Edogawa-ku, Tokyo, 133-0052
TEL 03-3673-1221
Homepage URL
Email ito@edogawa.or.jp

Sponsor
Institute Hiroyuki Ito
Institute
Department

Funding Source
Organization Edogawa Hospital
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
Address
Tel
Email

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
2015 Year 08 Month 07 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 Completed
Date of protocol fixation
2015 Year 05 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 06 Day
Last follow-up date
2015 Year 08 Month 07 Day
Date of closure to data entry
2015 Year 08 Month 07 Day
Date trial data considered complete
2015 Year 08 Month 07 Day
Date analysis concluded
2015 Year 08 Month 07 Day

Other
Other related information In the present cross-sectional study, we aimed to clarify the relationships between the duration of diabetes and the current statuses of 1) diabetic vascular complications, 2) the treatment for diabetes and 3) risk factors for atherosclerotic disease in elderly patients with type 2 diabetes in comparison with those in non-elderly subjects.

Management information
Registered date
2015 Year 08 Month 07 Day
Last modified on
2015 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021519

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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