UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008068
Receipt No. R000009504
Scientific Title Multicenter study of inhibitory effect of DPP-4 inhibitor (and/ ARB) on hepatic fibrosis in patients with diabetes and liver dysfunction
Date of disclosure of the study information 2012/06/01
Last modified on 2013/12/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Multicenter study of inhibitory effect of DPP-4 inhibitor (and/ ARB) on hepatic fibrosis in patients with diabetes and liver dysfunction
Acronym Multicenter study of inhibitory effect of DPP-4 inhibitor (and/ ARB) on hepatic fibrosis
Scientific Title Multicenter study of inhibitory effect of DPP-4 inhibitor (and/ ARB) on hepatic fibrosis in patients with diabetes and liver dysfunction
Scientific Title:Acronym Multicenter study of inhibitory effect of DPP-4 inhibitor (and/ ARB) on hepatic fibrosis
Region
Japan

Condition
Condition Diabetes Mellitus
Liver dysfunction
Hypertension
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the degree of hepatic fibrosis, presence of NASH in patients with type 2 diabetes, and to examine the inhibitory effects on hepatic fibrosis with DPP-4 inhibitors(and ARB).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Suppression of hepatic fibrosis
(Markers of fibrosis, such as hyaluronic acid, type IV collagen7S, and P3P. The degree of liver fibrosis by liver biopsy)
Key secondary outcomes Improvement of liver function
(TP, Alb, ChE, AST, ALT, LDH, ALP, r-GTP, T-Bil)

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) Patients over 20 years old
2) type 2 diabetes and ALT> 30
Key exclusion criteria 1) Patients with co-infection with hepatitis B virus
2) Patients with co-infection with hepatitis C virus
3) Patients with autoimmune hepatitis, primary biliary cirrhosis
4) Patients with alcohol addict (more than 20g/day)
5) Patients with insulin therapy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Yoshiji
Organization Nara Medical University
Division name Third department of Internal Medicine
Zip code
Address Shijyo-cho 840, Kashihara, Nara, Japan
TEL 0744-22-3051
Email 3naika@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryuichi Noguchi
Organization Nara Medical University
Division name Third department of Internal Medicine
Zip code
Address Shijyo-cho 840, Kashihara, Nara, Japan
TEL 0744-22-3051
Homepage URL
Email 3naika@naramed-u.ac.jp

Sponsor
Institute Third department of Internal Medicine, Nara Medical University
Institute
Department

Funding Source
Organization Third department of Internal Medicine, Nara Medical University
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
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 奈良県立医科大学附属病院(奈良県)
県立奈良病院(奈良県)
独立行政法人国立病院機構 奈良医療センター(奈良県)
県立五條病院(奈良県)
国保中央病院(奈良県)
県立三室病院(奈良県)
大和高田市立病院(奈良県)
高の原中央病院(奈良県)
西奈良中央病院(奈良県)
大倭病院(奈良県)
高宮病院(奈良県)
服部記念病院(奈良県)
平成記念病院(奈良県)
済生会御所病院(奈良県)
豊川総合病院(大阪府)
ベルランド総合病院(大阪府)
医真会八尾総合病院(大阪府)
福島県立医大 消化器内科(福島県)
公立藤田総合病院(福島県)
福島赤十字病院(福島県)
塙厚生病院(福島県)
大牟田市立病院(福岡県)

Other administrative information
Date of disclosure of the study information
2012 Year 06 Month 01 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 05 Month 10 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
2015 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Factors to consider the relevance and results

Management information
Registered date
2012 Year 05 Month 31 Day
Last modified on
2013 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009504

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.