UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044064 |
|---|---|
| Receipt number | R000050309 |
| Scientific Title | Investigation of a retrospective in-hospital database on surveying complications of patients with lifestyle-related diseases and their treatment |
| Date of disclosure of the study information | 2021/04/28 |
| Last modified on | 2021/04/28 12:33:20 |
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Basic information
Public title
Investigation of a retrospective in-hospital database on surveying complications of patients with lifestyle-related diseases and their treatment
Acronym
Investigation of a retrospective in-hospital database on surveying complications of patients with lifestyle-related diseases and their treatment
Scientific Title
Investigation of a retrospective in-hospital database on surveying complications of patients with lifestyle-related diseases and their treatment
Scientific Title:Acronym
Investigation of a retrospective in-hospital database on surveying complications of patients with lifestyle-related diseases and their treatment
Region
| Japan |
Condition
Condition
lifestyle-related diseases
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Neurology | Ophthalmology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the actual condition of complications in diabetic patients and other lifestyle-related diseases (hypertension, dyslipidemia, uric acid metabolism disorder, chronic kidney disease), and how various diabetes management and treatments suppress the onset and progression of complications. Clarify what you were doing. In addition to retinopathy, nephropathy, neuropathy, and atherosclerosis, which are complications of diabetes, other heart diseases (atrial fibrillation, etc.), cancer, and dementia will also be examined. To that end, digitize past in-hospital data in a way that can be compared with the results of the Asahi study.
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Period of the following events from the start of observation
Nephropathy
Retinopathy
Neuropathy
Macroangiopathy: ischemic heart disease (myocardial infarction, angina, cardiovascular reconstruction, etc.) Cerebrovascular accident (stroke, transient ischemic attack, etc.)
Heart failure, ASO, amputation of lower limbs.
Malignant tumor
Infection
Key secondary outcomes
Search for factors related to the primary endpoint. For diabetic patients, we will stratify insulin-introduced patients according to the duration of illness and glycemic control status, and examine the effect on the onset of the primary endpoint.
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
Patients visiting our hospital who are considered to be included in the comprehensive consent. Those who have an ID at the hospital during the entire period from the opening of the hospital to the present.
Key exclusion criteria
Those who do not agree with the comprehensive consent
Others who are judged to be inappropriate by the investigator
Target sample size
8000
Research contact person
Name of lead principal investigator
| 1st name | Akifumi |
| Middle name | |
| Last name | Kushiyama |
Organization
Meiji Pharmaceutical University
Division name
Dept. Pharmacotherapy
Zip code
2048588
Address
2-522-1, Noshio, Kiyose
TEL
0424958725
kushiyama@my-pharm.ac.jp
Public contact
Name of contact person
| 1st name | Akifumi |
| Middle name | |
| Last name | Kushiyama |
Organization
Meiji Pharmaceutical University
Division name
Dept. Pharmacotherapy
Zip code
2048588
Address
2-522-1, Noshio, Kiyose
TEL
0424958725
Homepage URL
kushiyama@my-pharm.ac.jp
Sponsor or person
Institute
The Institute for Adult Diseases, Asahi Life Foundation
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
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
the Committee of Ethics at the Institute for Adult Diseases, Asahi Life Foundation
Address
2-2-6, Nihonbashi Bakurocho, Chuo-ku, Tokyo
Tel
0336395501
a-kushiyama@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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 28 | 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
| 2015 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We have documented the comprehensive consent in the medical record survey.
In order to create a database with the cooperation of Meiji Pharmaceutical University, insert the following text regarding comprehensive consent.
"Medical data at our hospital may be used by our full-time staff as well as collaborators. In this case, the handling of the data and the publication of the results will be supervised by our researchers. "
In addition, the names of collaborators will be published on the website along with the research projects.
Collect the following survey items, such as the entry of the questionnaire at the start of the survey. Since 2000, data on tests and prescription drugs for which a ledger / database already exists will be acquired and combined. The onset of complications is as follows: each stage of retinopathy (SDR, PPDR, PDR), day of ophthalmic surgery, nephropathy (Stage2-5), neuropathy (autonomous neuropathy), atherosclerosis (cerebral blood vessels) Disorder, ischemic heart disease, PAD), gangrene, infectious disease, cancer, dementia.
1. Physical findings
2. Examination
3. Information on diabetic complications at the first visit
4. Treatment information
3) Obtain the following clinical information from the questionnaire and medical records.
1. Date of birth
2. Gender
3. Estimated age of onset of diabetes
4. Medical history
5. Diabetes family history
6. Life history (drinking, smoking)
7. Maximum past weight, age at maximum past weight
8. Disease type with diabetes
9. Diabetes treatment information
10. Receipt disease name and its date
11. Contents of medical information provision form
12. Last visit date and outcome
Management information
Registered date
| 2021 | Year | 04 | Month | 28 | Day |
Last modified on
| 2021 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050309
| Research Plan | |
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| Registered date | File name |
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