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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029697
Receipt No. R000033941
Scientific Title Examination of efficacy of selective sodium-glucose cotransporter-2 inhibitor (SGLT2I) for patients with type 2 diabetes mellitus complicated with nonalcoholic fatty liver disease / nonalcoholic steatohepatitis
Date of disclosure of the study information 2017/10/24
Last modified on 2018/10/28

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Basic information
Public title Examination of efficacy of selective sodium-glucose cotransporter-2 inhibitor (SGLT2I) for patients with type 2 diabetes mellitus complicated with nonalcoholic fatty liver disease / nonalcoholic steatohepatitis
Acronym Efficacy of SGLT2I on NAFLD/ NASH
Scientific Title Examination of efficacy of selective sodium-glucose cotransporter-2 inhibitor (SGLT2I) for patients with type 2 diabetes mellitus complicated with nonalcoholic fatty liver disease / nonalcoholic steatohepatitis
Scientific Title:Acronym Efficacy of SGLT2I on NAFLD/ NASH
Region
Japan

Condition
Condition Type 2 diabetes mellitus Nonalcoholic fatty liver disease
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to identify the efficacy of SGLT2I for NAFLD.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1. Identify change of liver enzyme and steatosis using biochemical measurements and ultrasonography after 24 weeks.
Key secondary outcomes Identify change of HbA1c, cytokine, adipokine, type 4 collagen 7S, and insulin after 24 weeks.

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

Not applicable
Gender Male and Female
Key inclusion criteria body mass index (BMI) > 22 kg/m2
hemoglobin A1c (HbA1c) > 6.5%.
Key exclusion criteria decompensated liver cirrhosis
hepatocellular carcinoma, or extrahepatic cancer
serum creatinine level < 2.0 mg/dL
pregnancy or lactation
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichi Hiasa
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code
Address Toon City, Ehime, Japan
TEL +81899605308
Email teruki-ygc@umin.ac.jp

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

Sponsor
Institute Ehime University Graduate School of Medicine
Institute
Department

Funding Source
Organization Non
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 10 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.degruyter.com/view/j/med
Number of participants that the trial has enrolled
Results
Forty-three patients with T2DM and NAFLD were enrolled (12 with biopsy-proven NASH and 31 with NAFLD diagnosed by ultrasonography). After 24 weeks, body weight, hemoglobin A1c (HbA1c), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase, body fat mass, and steatosis were significantly decreased compared to baseline measurements in patients with NASH. However, muscle mass was not reduced, and liver stiffness showed a statistically insignificant tendency to decrease. NAFLD patients also showed a significant reduction in body weight, HbA1c, AST, and ALT compared to baseline measurements.
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 Completed
Date of protocol fixation
2014 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
2017 Year 06 Month 30 Day
Date of closure to data entry
2017 Year 07 Month 30 Day
Date trial data considered complete
2017 Year 07 Month 30 Day
Date analysis concluded
2017 Year 08 Month 30 Day

Other
Other related information Patients received oral ipragliflozin (50 mg/day) once daily for 24 weeks. We recorded the results of physical examinations and routine biochemical studies. Body composition was evaluated using InBody720, and the controlled attenuation parameter for the quantification of liver steatosis and liver stiffness was measured by transient elastography in patients with NASH. We compared pre- and post-treatment continuous variables.

Management information
Registered date
2017 Year 10 Month 24 Day
Last modified on
2018 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033941

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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