UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018814 |
|---|---|
| Receipt number | R000021434 |
| Scientific Title | Effects of canagliflozin on the hepatic steatosis, adipose tissue and skeletal muscle in patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease / non-alcoholic steatohepatitis |
| Date of disclosure of the study information | 2015/08/28 |
| Last modified on | 2017/06/29 14:05:02 |
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Basic information
Public title
Effects of canagliflozin on the hepatic steatosis, adipose tissue and skeletal muscle in patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease / non-alcoholic steatohepatitis
Acronym
Effects of canagliflozin on hepatic steatosis, adipose tissue and skeletal muscle in patients with Type 2 diabetes mellitus with NAFLD/NASH
Scientific Title
Effects of canagliflozin on the hepatic steatosis, adipose tissue and skeletal muscle in patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease / non-alcoholic steatohepatitis
Scientific Title:Acronym
Effects of canagliflozin on hepatic steatosis, adipose tissue and skeletal muscle in patients with Type 2 diabetes mellitus with NAFLD/NASH
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus with NAFLD/NASH
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the ameliorating effect of a canagliflozin on hepatic steatosis and examination of changes in the areas of visceral/subcutaneous fat and skeletal muscle.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
A change in liver fat fraction after administrating a canagliflozin using MRI
Key secondary outcomes
-A change in hepatic CT HU using CT
-A change in visceral and subcutaneous fat cross sectional area using CT.
-A change in cross sectional area, CT HU and ratio of fat infiltration of skeletal muscles using CT.
-A change in CAP and liver stiffness
measurements by FibroScan.
-Evaluation of the degree of FDG accumulation of liver, brain, skeletal muscles using FDGPETCT.
-Changes of blood pressure, body weight, blood glucose(HbA1c,fasting plasma glucose),GA,HOMAbeta,CPRindex,insulin resistance(HOMAIR), NAFIC score, FIB4 index.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Implementation of FDG-PET/CT.
Plain CT, plain MRI,FDG-PET/CT and Fibroscan are performed twice for six months.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes who fulfilled the following criteria.
1) Patients with HbA1c equal to or greater than 6.0% and lesser than 9.0%.
2) Patients treated with diet, exercise or antidiabetic medications except SGLT2 inhibitor.
3) Patients with a BMI more than 20.
4) Patients with fatty liver diagnosed by abdominal US, and who have a diagnosis of NAFLD or NASH based on the definition of the medical treatment guide of NASH, NAFLD of the Japan society of hepatology.
5) Patients that blood pressure and lipids are well controlled.
6)Having provided voluntary written consent for participation in this study.
Key exclusion criteria
-Patients corresponding to any of the following are inapplicable
-Patients with a history of allergy to any component of the study medications
-Patients with severe ketosis or diabetic coma.
-Patients with severe infections, perioperative status, or severe trauma
-Patients with severe complications( liver disease, renal disease, mental disorder, cancer)
-Patients that we may be running out of plasticity of enforcement for image or analysis of the examination, for example, remarkable spinal column scoliosis
-Patients who has difficulty in MRI study implementation including having a Implantable cardioverter-defibrillator and internal metal et al
-Pregnancy or lactation in women
-Inadequacy of usingig this therapy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Terauchi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Endocrinology and Metabolism
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2639
terauchi@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuki Tajima |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Endocrinology and Metabolism
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2639
Homepage URL
kztajima@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 28 | 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
| 2015 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 26 | Day |
Last modified on
| 2017 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021434
