UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012513 |
|---|---|
| Receipt number | R000014647 |
| Scientific Title | The improvement effect of liver dysfanction and inhibitory effect of fibrosis marker by sitagliptin or repaglinide treatment for fatty liver(liver dysfunction) patients with type2 diabetes mellitus. |
| Date of disclosure of the study information | 2014/12/07 |
| Last modified on | 2018/06/11 14:08:25 |
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Basic information
Public title
The improvement effect of liver dysfanction and inhibitory effect of fibrosis marker by sitagliptin or repaglinide treatment for fatty liver(liver dysfunction) patients with type2 diabetes mellitus.
Acronym
The improvement effect of liver dysfanction and inhibitory effect of fibrosis marker by sitagliptin or repaglinide treatment for fatty liver(liver dysfunction) patients with type2 diabetes mellitus.
Scientific Title
The improvement effect of liver dysfanction and inhibitory effect of fibrosis marker by sitagliptin or repaglinide treatment for fatty liver(liver dysfunction) patients with type2 diabetes mellitus.
Scientific Title:Acronym
The improvement effect of liver dysfanction and inhibitory effect of fibrosis marker by sitagliptin or repaglinide treatment for fatty liver(liver dysfunction) patients with type2 diabetes mellitus.
Region
| Japan |
Condition
Condition
Diabetes Mellitus Liver dysfunction
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The improvement effect of both blood sugar and liver function including fatty liver improvement and fibrosis markers inhibition by the sitagliptin treatment in early type 2 diabetes mellitus patients with fatty liver (liver dysfunction) who are not having the existing medical treatment is verified, and the effect of sitagliptin except pancreas is examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
NAFIC score(Ferritin, IRI, Type4collagen 7s)
Key secondary outcomes
diagnostic imaging, blood test , adiponecti, GLP-1(Active form), free fatty acid
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A: sitagliptin 50mg QD
Interventions/Control_2
Group B: repaglinide 0.25mg TID
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who have fatty liver by picture evaluation ( abdomen echo check, abdomen CT inspection)
2)Patients who have abnormalities in AST, ALT, or gamma-GTP
3)Patients who have abnormalities in TG, T-CHO, or FFA
4)Patient who have abnormalities in either IV type collagen S or ferritin
Patients who fulfilled above 1) and 2)as indispensable condition, and either 3) or 4), or both 3) and 4)
Key exclusion criteria
1) Patients who have renal dysfunction 2) Patients whose medicine or its dosage changed during the study duration if antihypertensive drug, antilipidemial drug or medicine which effects on other liver functions is used.
3) Patients who are considered inappropriate as a target patient by a physician-in-charge
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Fukunishi |
Organization
Osaka Medical College Hospital
Division name
Second internal medicine
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1211
in2104@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Fukunishi |
Organization
Osaka Medical College Hospital
Division name
Second internal medicine
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1211
Homepage URL
in2104@ph.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Medical College Hospital, Ishikiriseiki Hospital, Shiroyama Hospital, Sugimoto Clinic, Seikeikai Hospital, Taisyou Hospital, First Towakai Hospital, Hanwasumiyosi General Hospital, Hokusetsu General Hospital
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 07 | 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
| 2012 | Year | 07 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 07 | Day |
Last modified on
| 2018 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014647
