UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018591 |
|---|---|
| Receipt number | 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 | 2024/01/09 12:29:11 |
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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 | Hiroyuki |
| Middle name | |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism and Kidney Disease
Zip code
133-0052
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo, 133-0052
TEL
03-3673-1221
ito@edogawa.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism and Kidney Disease
Zip code
133-0052
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo, 133-0052
TEL
03-3673-1221
Homepage URL
ito@edogawa.or.jp
Sponsor or person
Institute
Edogawa Hospital
Institute
Department
Personal name
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
Ethics Committee of Edogawa Hospital
Address
2-24-18, Higashikoiwa, Edogawa-Ku, Tokyo
Tel
03-3673-1221
ito@edogawa.or.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
| 2015 | Year | 08 | Month | 07 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/ggi.12654
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/ggi.12654
Number of participants that the trial has enrolled
1436
Results
As the duration of diabetes increased, the age, insulin therapy and HbA1c increased in both the elderly and non-elderly groups, whereas the urinary CPR and eGFR decreased. The duration of diabetes was significantly associated with the prevalence of diabetic retinopathy, nephropathy and neuropathy, but not with CVD, CHD or PAD in the elderly patients. The duration of diabetes showed a significant association with the prevalence of both diabetic micro- and macroangiopathy in the non-elderly patients.
Results date posted
| 2024 | Year | 01 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2015 | Year | 12 | Month | 04 | Day |
Baseline Characteristics
1436 patients with type 2 diabetes
Participant flow
1436 patients with type 2 diabetes
Adverse events
N/A
Outcome measures
Diabetic micro- and macroangiopathy
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 01 | Day |
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
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021519
