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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name