UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of hypoglycemic agents in nonalcoholic fatty liver disease with type 2 diabetes
Acronym	Efficacy and safety of hypoglycemic agents in nonalcoholic fatty liver disease with type 2 diabetes
Scientific Title	Efficacy and safety of hypoglycemic agents in nonalcoholic fatty liver disease with type 2 diabetes
Scientific Title:Acronym	Efficacy and safety of hypoglycemic agents in nonalcoholic fatty liver disease with type 2 diabetes
Region	Japan

Condition
Condition	nonalcoholic fatty liver disease with type 2 diabetes
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the efficacy and safety of various hypoglycemic agents in NAFLD patients with type 2 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in liver stiffness 1 year after administration from baseline
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)age =>20 years 2)Type 2 diabetes 3)Patients with NAFLD diagnosed by clinical data 4)Patients provided with informed consent
Key exclusion criteria	1) daily alcohol consumption =>30 g for males and =>20 g for females 2) other chronic liver diseases, such as viral hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, Wilson disease, and hemochromatosis 3) pregnancy and lactation 4) Others judged unsuitable by researchers
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Taeang Middle name Last name Arai
Organization	Nippon Medical School
Division name	Division of Gastroenterology and Hepatology
Zip code	113-8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan.
TEL	03-3822-2131
Email	taeangpark@yahoo.co.jp

Public contact
Name of contact person	1st name Taeang Middle name Last name Arai
Organization	Nippon Medical School
Division name	Division of Gastroenterology and Hepatology
Zip code	113-8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan.
TEL	03-3822-2131
Homepage URL
Email	taeangpark@yahoo.co.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nippon Medical School Hospital Ethics Committee
Address	1-1-5,Sendagi,Bunkyo-ku,Tokyo,Japan.
Tel	03-3822-2131
Email	nms_fuzokurinri@nms.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	2021 Year 09 Month 27 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	2021 Year 07 Month 12 Day
Date of IRB	2021 Year 07 Month 12 Day
Anticipated trial start date	2021 Year 09 Month 27 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Proactively observe the efficacy and safety of various hypoglycemic agents in patients with NAFLD with type 2 diabetes

Management information
Registered date	2021 Year 09 Month 27 Day
Last modified on	2021 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052024