UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Identification of the actual states of the occurrence of hepatocellular carcinoma in patients with type 2 diabetes.
Title of the study (Brief title)	the occurrence of hepatocellular carcinoma in type 2 diabetic patients.
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of the present study is to establish the high risk group on the occurrence of hepatocellular carcinoma in type 2 diabetes.
Basic objectives2	Others
Basic objectives -Others	observational study
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of several data showed below between HCC-developed and HCC-undeveloped type 2 diabetic patients. 1) gender, age, BMI, abdominal circumference, maximum body weight, treatment of diabetes, hypertension and dislipidemia, history of alcohol 2) blood examination: number of Plates 3) Blood chemistry: Albumin, AST, ALT, T-bil, BUN, s-Cre, GGT, ALP, T-Chol, TG, HDL-C, UA, blood glucose level, HbA1c, glicoalbumin 4) coagulation: prothrombin time
Key secondary outcomes

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	Subjects with type 2 diabetes who has non-B or non-C hepatocellular cancer and were followed by specialists of diabetes for at least 5 years were enrolled in this study. Moreover, subjects with diabetes who were enrolled in the "Okanoue study designed from Ministry of Health, Labour and Welfare: The observational study of NASH for the clarification of clinical states, diagnostic procedure and novel therapeutics."
Key exclusion criteria	1) Subjects who were diagnosed as hepatocellular carcinoma at the age of 25 or less. 2) Subjects who were diagnosed as chronic hepatitis B or chronic hepatitis C. 3) Subjects who were not sutbable to enroll the study by physician in charge.
Target sample size	600

Research contact person
Name of lead principal investigator	Eiichi Araki
Organization	Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University
Division name	Department of Metabolic Medicine
Address	1-1-1 Honjo, Chuo, Kumamoto, Kumamoto, 860-8556, Japan
TEL	0963735169
Email	earaki@gpo.kumamoto-u.ac.jp

Public contact
Name of contact person	Takeshi Matsumura
Organization	Kumamoto University Hospital
Division name	Diabetes, Metabolism and Endocrinology
Address	1-1-1 Honjo, Chuo, Kumamoto, Kumamoto, 860-8556, Japan
TEL	0963735169
Homepage URL
Email	takeshim@gpo.kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development: AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Department of Gastroenterology, The University of Tokyo Hospital Department of Diabetes and Metabolic Diseases, The University of Tokyo Hospital
Name of secondary funｄer(s)

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	2017 Year 02 Month 21 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 10 Month 25 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We are now recruiting subjects with type 2 diabetes who has non-B or non-C hepatocellular cancer and were followed by specialists of diabetes for at least 5 years.

Management information
Registered date	2017 Year 02 Month 21 Day
Last modified on	2017 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030140