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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041029
Receipt No. R000046856
Scientific Title Actual condition survey for the patients with type 2 diabetes mellitus and examination of both predictive and exacerbating factors for nonalcoholic fatty liver disease and arteriosclerotic disease in type 2 diabetes mellitus
Date of disclosure of the study information 2020/07/10
Last modified on 2020/07/08

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Basic information
Public title Actual condition survey for the patients with type 2 diabetes mellitus and examination of both predictive and exacerbating factors for nonalcoholic fatty liver disease and arteriosclerotic disease in type 2 diabetes mellitus
Acronym Examination of actual condition and predictive factor for NAFLD and arteriosclerotic disease
Scientific Title Actual condition survey for the patients with type 2 diabetes mellitus and examination of both predictive and exacerbating factors for nonalcoholic fatty liver disease and arteriosclerotic disease in type 2 diabetes mellitus
Scientific Title:Acronym Examination of actual condition and predictive factor for NAFLD and arteriosclerotic disease
Region
Japan

Condition
Condition Nonalcoholic fatty liver disease (NAFLD)
Nonalcoholic steatohepatitis (NASH)
Type 2 diabetes mellitus
Cardiovascular disease
Arteriosclerotic disease
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Cardiology
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to clarify the relationship between the pathophysiology of NAFLD and arteriosclerotic disease among type 2 diabetes mellitus by conducting actual condition survey of nonalcoholic fatty liver disease (NAFLD) and arteriosclerotic disease. Next, we will explore other factor associated with arteriosclerotic disease. Finally, we will investigate the predictive factor for onset and progression of NAFLD and arteriosclerotic disease, and further examine the infuluence of NAFLD and arteriosclerotic disease on prognosis, and onset and progression of metabolic disease and cancer.
Basic objectives2 Others
Basic objectives -Others usefulness
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1. Examine the relationship between NAFLD and arteriosclerotic disease.
2. Evaluate the correlation between NAFLD related factor and arteriosclerotic change.
3. Compare the risk factor for atherosclerosis between NAFLD and non-NAFLD patients.
4. Explore the factor associated with onset and progress of arteriosclerotic change.
5. Explore the factor associated with onset and progress of NAFLD.
6. Investigate the influence of the NAFLD and arteriosclerotic change on onset of metabolic diseases, cancer, and prognosis.
Key secondary outcomes (1) Explore the factors associated with atherosclerotic changes.

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Outpatients from April 1998 to July 2024 who visited the facilities which is related with Ehime University Graduate School of Gastroenterology, Endocrine and Metabolism.
2.Male and female over eighteen years of age
3.Patients who have already been or newly diagnosed with diabetes.
4.Patients, who are in regular visits, agree to participate in this survey by written consent
5.Patients, who have not attended a hospital, do not have no intention of not participating by opt-out.
Key exclusion criteria 1. Patients with pregnancy or lactation
2. Patients judged for inappropriate by doctor
Target sample size 4000

Research contact person
Name of lead principal investigator
1st name Teruki
Middle name
Last name Miyake
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code 7910295
Address Shitsukawa, Toon City, Ehime, Japan
TEL 0899605308
Email teruki-ygc@umin.ac.jp

Public contact
Name of contact person
1st name Teruki
Middle name
Last name Miyake
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code 7910295
Address Shitsukawa, Toon City, Ehime, Japan
TEL +81899605308
Homepage URL
Email teruki-ygc@umin.ac.jp

Sponsor
Institute Ehime University
Institute
Department

Funding Source
Organization Ehime University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Yawatahama General City Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee of Ehime University Hospital
Address Shitsukawa, Toon City, Ehime, Japan
Tel +81899605914
Email rinri@m.ehime-u.ac.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
2020 Year 07 Month 10 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 Open public recruiting
Date of protocol fixation
2019 Year 09 Month 24 Day
Date of IRB
2019 Year 09 Month 24 Day
Anticipated trial start date
2020 Year 07 Month 08 Day
Last follow-up date
2024 Year 07 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 clarify the relationship between the pathophysiology of NAFLD and arteriosclerotic disease among type 2 diabetes mellitus by conducting actual condition survey of nonalcoholic fatty liver disease (NAFLD) and arteriosclerotic disease. Next, we will explore other factor associated with arteriosclerotic disease. Finally, we will investigate the predictive factor for onset and progression of NAFLD and arteriosclerotic disease, and further examine the infuluence of NAFLD and arteriosclerotic disease on prognosis, and onset and progression of metabolic disease and cancer.

Management information
Registered date
2020 Year 07 Month 08 Day
Last modified on
2020 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046856

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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