UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045412 |
|---|---|
| Receipt number | R000051812 |
| Scientific Title | Examination of changes in nutritional status and body composition after SGLT2 inhibitor administration for patients with liver cirrhosis and with diabetes |
| Date of disclosure of the study information | 2021/09/20 |
| Last modified on | 2024/03/12 15:18:54 |
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Basic information
Public title
Examination of changes in nutritional status and body composition after SGLT2 inhibitor administration for patients with liver cirrhosis and with diabetes
Acronym
Changes in nutritional status and body composition after SGLT2 inhibitor administration
Scientific Title
Examination of changes in nutritional status and body composition after SGLT2 inhibitor administration for patients with liver cirrhosis and with diabetes
Scientific Title:Acronym
Changes in nutritional status and body composition after SGLT2 inhibitor administration
Region
| Japan |
Condition
Condition
Non alcoholic fatty liver disease
diabetes mellites
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
SGLT2 inhibitors are expected to have the effect of suppressing postprandial hyperglycemia and glycemic fluctuation in liver cirrhosis with diabetes, but their effects on nutritional status, body composition components including water, muscle mass, and fat mass, and liver function are unknown. We will investigate the effects of SGLT2 inhibitors about that in patients with liver cirrhosis and diabetes.
Basic objectives2
Others
Basic objectives -Others
SGLT2 inhibitors are expected to have the effect of suppressing postprandial hyperglycemia and glycemic fluctuation in liver cirrhosis with diabetes, but their effects on nutritional status, body composition components including water, muscle mass, and fat mass, and liver function are unknown. We will investigate the effects of SGLT2 inhibitors about that in patients with liver cirrhosis and diabetes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in nutritional status due to SGLT2 inhibitor treatment in patients with liver cirrhosis
Key secondary outcomes
Changes in body composition (water, fat mass, muscle mass) after 6 months
Changes in liver hardness and liver reserve after 6 months
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) 20 years old and over
(2) Compensatory cirrhosis with diabetes (Child-Pugh classification A or B, regardless of the cause of cirrhosis)
(3) Those who are newly started to administer SGLT2 inhibitors
Key exclusion criteria
(1) Under 20 years old
(2) Decompensated cirrhosis (Child-Pugh classification C)
(3) Patients who are already taking SGLT2 inhibitors or who have been found to be allergic to SGLT2 inhibitors in the past
(4) Patients using insulin preparations for diabetes treatment
(5) Patients who are pregnant or may become pregnant
(6) Other patients who the attending physician has determined to be unable to participate in the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Takahashi |
Organization
Saga University Hospital
Division name
Liver center
Zip code
8498501
Address
Nabeshima 5-1-1, Saga city
TEL
0952342362
takahas2@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Kuwashiro |
Organization
Saga Medical School
Division name
Hepatology, Diabetes and Endocrinology
Zip code
8498501
Address
Nabeshima 5-1-1, Saga city
TEL
0952342362
Homepage URL
f8451@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
none
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
Saga University Hospital, Clinical Research Center
Address
Nabeshima 5-1-1, Saga city
Tel
0952-34-3400
kenkyu-shinsei@ml.cc.saga-u.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | 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
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will compared body composition, blood test data, liver function, etc. between pre treatment of SGLT2 inhibitor administration and post SGLT2 inhibitor administration in liver cirrhosis with diabetes.
Management information
Registered date
| 2021 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | 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=R000051812
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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