UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022155
Receipt No. R000025530
Scientific Title Effect of SGLT-2 inhibitors on Hepatic Steatosis and Fibrosis Estimated by using Fibroscan with Type 2 Diabetes Suffering from Non-alcoholic Fatty Liver Disease
Date of disclosure of the study information 2016/05/01
Last modified on 2018/03/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of SGLT-2 inhibitors on Hepatic Steatosis and Fibrosis Estimated by using Fibroscan with Type 2 Diabetes Suffering from Non-alcoholic Fatty Liver Disease
Acronym STHENIC trial
Scientific Title Effect of SGLT-2 inhibitors on Hepatic Steatosis and Fibrosis Estimated by using Fibroscan with Type 2 Diabetes Suffering from Non-alcoholic Fatty Liver Disease
Scientific Title:Acronym STHENIC trial
Region
Japan

Condition
Condition Type 2 Diabetes Suffering from
Non-alcoholic Fatty Liver Disease
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of SGLT-2 inhibitors on hepatic steatosis and fibrosis estimated by fibroscan, visceral fat area measured, Body composition and endothelial function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of hepatic steatosis between SGLT-2 inhibitors group(Additional treatment with SGLT-2 inhibitor) and control group (aggressive conventional treatment without SGLT-2 inhibitors) at 24 weeks after starting this trial.
Key secondary outcomes The change of visceral fat area
The change of body composition
The change of endothelial function
The change of NAFLD fibrosis score,NAFIC score,FIB-4index and M2BPGi
The change of oxidative,apoptosis markers and inflammatory cytokines.
These changes will be evaluated at base line, 24 weeks between two groups


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Additional treatment with SGLT-2 inhibitor (SGLT-2 inhibitor group) for 24 weeks administration.
Interventions/Control_2 Aggressive conventional treatment (control).
(Excluding treatment with SGLT-2inhibitor and increase a dose of metformin,pioglitazone and GLP-1 receptor agonist)
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 1. Type 2 diabetes patients
2. Diagnosed fatty liver by sonography
3. Oral administration of metformin
4. Satisfying diagnostic criteria of NAFLD

Patients were prospectively assigned to either additional treatment with SGLT-2 inhibitors(n=30) or aggressive conventional treatment (control, n=30) for 6 months.
Key exclusion criteria 1) Type 1 diabetes
2) Severe diabetic complications such as ketoacidosis
3) Severe renal dysfunction(estimated glomerular filtration rate [eGFR] < 30 mL/min/)
4) Pregnant or nursing women and those who might be pregnant
5) Chronic heart failure,
6) Haemodialysis,
7) A history of stroke and cardiovascular events,
8) Any patient whom the investigator judged to be inappropriate for this study. Patients were given detailed explanations of the study protocol.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshimasa Aso
Organization Dokkyo Medical University
Division name Endocrinology and Metabolism
Zip code
Address 880, Kitakobayashi, Mibu, Shimotsugagun, Tochigi
TEL 0282-87-2150
Email yaso@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunihiro Suzuki
Organization Dokkyo Medical University
Division name Endocrinology and Metabolism
Zip code
Address 880, Kitakobayashi, Mibu, Shimotsugagun, Tochigi
TEL 0282-87-2150
Homepage URL
Email kuni-s@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

Funding Source
Organization Dokkyo Medical University
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
2016 Year 05 Month 01 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 Completed
Date of protocol fixation
2016 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 09 Month 30 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 04 Month 30 Day
Last modified on
2018 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025530

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.