UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005349 |
|---|---|
| Receipt number | R000006355 |
| Scientific Title | The evaluation of the efficacy of sitagliptin for NASH/NAFLD patients-a multicenter open-label study- |
| Date of disclosure of the study information | 2011/03/30 |
| Last modified on | 2011/03/30 21:10:30 |
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Basic information
Public title
The evaluation of the efficacy of sitagliptin for NASH/NAFLD patients-a multicenter open-label study-
Acronym
The treatment with sitagliptin for NASH/NAFLD
Scientific Title
The evaluation of the efficacy of sitagliptin for NASH/NAFLD patients-a multicenter open-label study-
Scientific Title:Acronym
The treatment with sitagliptin for NASH/NAFLD
Region
| Japan |
Condition
Condition
nonalcoholic fatty liver disease/nonalcoholic steatohepatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of the effiacy of sitagliptin for NAFLD/NASH
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the findings of liver histology
Key secondary outcomes
improvement in liver function and diabetes
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
sitagliptin
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) type 2 diabetic patients without medicines for 3 months
2) ALT more than 30 IU/L, in spite of dietary educations
3) patients, who were diagnosed as NASH/NAFLD on the basis of liver histology
Key exclusion criteria
1) drinkers (ethanol intake > 20g/day)
2) HBsAg and/or HCV Ab positive patients
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Sumida |
Organization
Nara City Hospital
Division name
Center for Digestive and Liver Diseases
Zip code
Address
Kidera-cho 1-50-1, Nara, Japan
TEL
0742-24-1251
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Sumida |
Organization
Nara City Hospital
Division name
Center for Digestive and Liver Diseases
Zip code
Address
TEL
Homepage URL
sumida@nara-jadecom.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine, Department of Gastroenterology and Hepatology
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
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
| 2011 | Year | 03 | Month | 30 | 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
| 2011 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | 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
| 2011 | Year | 03 | Month | 30 | Day |
Last modified on
| 2011 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006355
