UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030498 |
|---|---|
| Receipt number | R000034810 |
| Scientific Title | Effect of Dapagliflozin (Forxiga) on hepatic lipid content and microbiota in patients with nonalcoholic fatty liver disease complicated by type 2 diabetes mellitus |
| Date of disclosure of the study information | 2017/12/20 |
| Last modified on | 2023/12/27 12:00:54 |
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Basic information
Public title
Effect of Dapagliflozin (Forxiga) on hepatic lipid content and microbiota in patients with nonalcoholic fatty liver disease complicated by type 2 diabetes mellitus
Acronym
Effect of Dapagliflozin (Forxiga) on hepatic lipid content and microbiota in patients with nonalcoholic fatty liver disease complicated by type 2 diabetes mellitus
Scientific Title
Effect of Dapagliflozin (Forxiga) on hepatic lipid content and microbiota in patients with nonalcoholic fatty liver disease complicated by type 2 diabetes mellitus
Scientific Title:Acronym
Effect of Dapagliflozin (Forxiga) on hepatic lipid content and microbiota in patients with nonalcoholic fatty liver disease complicated by type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to reveal the efficacy of using SGLT2i(Dapagliflozin) about hepatic lipid content, hepatitis,and microbiota in patients with nonalcoholic fatty liver disease complicated by type 2 diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the change of hepatic lipid content measured by MRS at 24 weeks after starting
trial.
Key secondary outcomes
Evaluation of the change of blood and urine examination at 4,12, and 24 weeks after starting
trial.
Evaluation of the change of microbiota at 24 weeks after starting trial.
Evaluation of the change of body composition
measured by InBody at 12 and 24 weeks after starting trial.
Evaluation of the change of CAP and LSM measured by Fibroscan at 12 and 24 weeks after starting trial.
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Orally administration of 5mg Dapagliflozin once a day for 24weeks.
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. Subjects appropriately diagnosed as type 2 DM by the latest report of the expert committee on the diagnosis and classification of diabetes mellitus
2. Patients who does not use other anti DM drugs within 8 weeks before consenting
3. Patients who have been treated with diet and exercise therapy
4. ALT >= 30IU/L or Fatty liver measured by ultra sonography
5. BMI >= 25kg/m2
6. Patients who can give their consent in a written form
Key exclusion criteria
1. Patient who have alcohol intake more than
210g/week ethanol for males or 140g/week ethanol for females.
2. Patients diagnosed viral hepatitis, autoimmune hepatitis, primary biliary cholangitis, drug-induced liver disease, biliary disorder, shock liver, hemochromatosis, Wilson's disease, and alpha1-antitrypsin deficiency
3. Patients diagnosed hepatic cirrhosis
4. Patients with a history of diabetic ketoacidosis
5. Type 1 diabetes mellitus or secondary diabetes
6. Serious renal dysfunction (serum Cre 1.3mg/dl or eGFR<45ml/min/1.73m2)
7. Pregnancy or possible pregnancy and breast feeding
8. Patients who had cerebral stroke, cerebral infarction, urinary infection, or genital infection within 12 weeks before giving their consent
9. Patients who had myocardial infarction, angina pectoris or atrial fibrillation
10. Patient with inability to take the drug by mouse
11. History of hypersensitivity to any of the ingredients of the study drug
12. Patient with contraindications to the study drug
13. In addition, when principal investigator or researcher deems inappropriate as a study subject
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tatehiro |
| Middle name | |
| Last name | Kagawa |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterology
Zip code
259-1143
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
kagawa@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Tsuruya |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterology
Zip code
259-1143
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
ktsuruya@tokai-u.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
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
Research Ethics Committee, Tokai University School of Medicine
Address
143 Shimokasuya, Isehara, Kanagawa
Tel
0463-93-1121
tokai-rec@tsc.u-tokai.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
東海大学医学部付属病院（神奈川県）
東海大学医学部付属大磯病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 20 | 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
17
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
| 2017 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | 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
| 2017 | Year | 12 | Month | 20 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034810
