UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022155 |
|---|---|
| Receipt number | 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 08:51:42 |
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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
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
kuni-s@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025530
