UMIN-CTR Clinical Trial

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