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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044064
Receipt No. 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

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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
Email 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
Email kushiyama@my-pharm.ac.jp

Sponsor
Institute The Institute for Adult Diseases, Asahi Life Foundation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050309

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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