UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041029 |
|---|---|
| Receipt number | 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 00:30:46 |
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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
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
teruki-ygc@umin.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046856
