UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015744 |
|---|---|
| Receipt number | R000018320 |
| Scientific Title | Asahi Diabetes Complications Study |
| Date of disclosure of the study information | 2014/11/26 |
| Last modified on | 2024/12/12 11:20:04 |
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Basic information
Public title
Asahi Diabetes Complications Study
Acronym
Asahi Diabetes Complications Study
(Asahi study)
Scientific Title
Asahi Diabetes Complications Study
Scientific Title:Acronym
Asahi Diabetes Complications Study
(Asahi study)
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the reality of diabetic complications and to elucidate the effect of diabetes care on the incidence and progression of diabetic complications, particularly in the urban area.
Furthermore, this study investigates the relationship between blood glucose fluctuation patterns and onset and progression of diabetic complications.
Basic objectives2
Others
Basic objectives -Others
Observational epidemiological study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Nephropathy
The first period: consecutive 2 measured albuminuria in patients without microalbuminuria (urinary albumin/ creatinine ratio, 30mg/g Cr or greater)
The second period: appearance of overt proteinuria (urinary albumin/ creatinine ratio, 300mg/g Cr or greater), > 2-fold increases in serum creatinine, eGFR 30 ~ 40% reduction, or initiation of dialysis in those with microalbuminuria.
2. Retinopathy
Development of retinopathy or progression of disease from simple, non-proliferative retinopathy to proliferative retinopathy or blindness.
3. Macroangiopathy
Ischemic heart disease (e.g. cardiac revascularization, myocardial infraction), heart failure requiring hospitalization, cerebrovascular disease (e.g. cerebral hemorrhage or cerebral infarction requiring hospitalization) except transient cerebral ischemic attack.
Lower extremity amputation, peripheral revascularization.
4. Malignancy
Mortality from malignant tumor (hepatocellular carcinoma, pancreatic carcinoma, colorectal cancer etc.)
5. Mild cognitive impairment
Appearance of mild cognitive impairment (MOCA-J score of 25 or less)
6.Sarcopenia
Appearance of sarcopenia (AGWS: Diagnostic criteria for sarcopenia in Asians)
7. Decline in ADL
DASC8 (Category 1: 10 points or less, Category 2: 11-16 points, Category 3: 17 points or more)
Key secondary outcomes
1.all-cause mortality
2.complication
retinopathy: photocoagulation, vitreous surgery, blindness
neuropathy: ulcer or gangrene
malignancy: incidence of malignancy
3.medical expenses
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
Type 1 and type 2 diabetes mellitus
Key exclusion criteria
1)Patient without diabetes
2)Impaired glucose tolerance
3)Other types of diabetes mellitus due to specific causes
4)Gestational diabetes mellitus
5)Overt diabetes in pregnancy
6)Patients who are difficult to judge whether to participate in the study
7)Patient judged inappropriate for the doctor in charge
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Kasuga |
Organization
The Institute of Medical Science, Asahi Life Foundation
Division name
Director
Zip code
1030002
Address
2-2-6, Nihonbashi Bakurocho, Chuo-ku, Tokyo
TEL
03-3639-5501
m-kasuga@asahi-life.or.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Yoshida |
Organization
The Institute of Medical Science, Asahi Life Foundation
Division name
Division of Diabetes and Metabolism
Zip code
1030002
Address
2-2-6, Nihonbashi Bakurocho, Chuo-ku, Tokyo
TEL
03-3639-5501
Homepage URL
y-yoshida@asahi-life.or.jp
Sponsor or person
Institute
The Institute of Medical Science, Asahi Life Foundation
Institute
Department
Personal name
Funding Source
Organization
The Institute of Medical Science, Asahi Life Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee , the Institute of Medical Science, Asahi Life Foundation
Address
2-2-6, Nihonbashi Bakurocho, Chuo-ku, Tokyo
Tel
0336395501
s-nakayama@asahi-life.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
公益財団法人朝日生命成人病研究所附属医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | 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
858
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
| 2014 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study is to investigate the reality of diabetic complications and to elucidate the effect of diabetes care on the incidence and progression of retinopathy, nephropathy, neuropathy, and arteriosclerotic diseases, particularly in the urban area. In addition to diabetic complications, we will investigate the relationship between diabetes care and malignancy or death is investigated.
Additional studies on cognitive dysfunction and sarcopenia and assessment of blood glucose patterns by Is CGM are being added in January 2020.
The extension of the study period for this research was registered separately as a follow-up study. However, as it was an extension of the Asahi Study, it was thought that it should be the same, so the registration for the follow-up study was withdrawn and the end date of the follow-up for this study was changed to the final day of the extension of the study period (December 12, 2024 entry).
Management information
Registered date
| 2014 | Year | 11 | Month | 23 | Day |
Last modified on
| 2024 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018320
