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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030498
Receipt No. 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 2018/06/30

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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
Middle name
Last name Tatehiro Kagawa
Organization Tokai University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 143 Shimokasuya, Isehara, Kanagawa
TEL 0463-93-1121
Email kagawa@tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kota Tsuruya
Organization Tokai University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 143 Shimokasuya, Isehara, Kanagawa
TEL 0463-93-1121
Homepage URL
Email ktsuruya@tokai-u.jp

Sponsor
Institute Tokai University
Institute
Department

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
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 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
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 Open public recruiting
Date of protocol fixation
2017 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
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
2018 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034810

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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