UMIN-CTR Clinical Trial
| 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 (Ver. 1) |
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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 | |
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| Condition | |||||
| Condition | Nonalcoholic fatty liver disease (NAFLD)
Nonalcoholic steatohepatitis (NASH) Type 2 diabetes mellitus Cardiovascular disease Arteriosclerotic disease |
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| Classification by specialty |
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| 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 | |
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| Randomization | |
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| Blinding | |
| Control | |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | |
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| Eligibility | ||||
| Age-lower limit |
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| 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. |
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| Key exclusion criteria | 1. Patients with pregnancy or lactation
2. Patients judged for inappropriate by doctor |
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| Target sample size | 4000 | |||
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| 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 | |||||||
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| Name of contact person |
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| 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 | |
| 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 |
| rinri@m.ehime-u.ac.jp | |
| Secondary IDs | |
| Secondary IDs | NO |
| Study ID_1 | |
| Org. issuing International ID_1 | |
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| IND to MHLW | |
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| Related information | |
| URL releasing protocol | |
| Publication of results | Unpublished |
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| Recruitment status | Open public recruiting | ||||||
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| 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. |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046856 |
