UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008068 |
|---|---|
| Receipt number | 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 | 2026/06/18 14:22:21 |
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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 | Hitoshi |
| Middle name | |
| Last name | Yoshiji |
Organization
Nara Medical University
Division name
Third department of Internal Medicine
Zip code
634-8522
Address
Shijyo-cho 840, Kashihara, Nara, Japan
TEL
0744-22-3051
3naika@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryuichi |
| Middle name | |
| Last name | Noguchi |
Organization
Nara Medical University
Division name
Third department of Internal Medicine
Zip code
634-8522
Address
Shijyo-cho 840, Kashihara, Nara, Japan
TEL
0744-22-3051
Homepage URL
3naika@naramed-u.ac.jp
Sponsor or person
Institute
Third department of Internal Medicine, Nara Medical University
Institute
Department
Personal name
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
Nara Medical University
Address
Shijyo-cho 840, Kashihara, Nara, Japan
Tel
0744223051
ychiken@naramed-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
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
https://www.spandidos-publications.com/10.3892/br.2016.569/download?utm_source=chatgpt.com
Publication of results
Partially published
Result
URL related to results and publications
https://www.spandidos-publications.com/10.3892/br.2016.569/download?utm_source=chatgpt.com
Number of participants that the trial has enrolled
39
Results
In conclusion, DPP4-I administration resulted in decreased NAFIC scores, demonstrating the efficacy of DPP4-I against NAFLD progression. These results indicate that DPP4-I may represent a potential new therapeutic strategy for the prevention of NAFLD progression in NAFLD patients with type 2 diabetes in the future.
Results date posted
| 2026 | Year | 06 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study was a single arm, multi-center, non randomized study of NAFLD patients with type 2 diabetes that were recruited from 8 centers in Japan between June 2012 and December 2013. All the patients received 25 mg/day of alogliptin for 12 months.
Participant flow
Patients. A total of 59 patients were enrolled in the study between June 2012 and December 2013. A total of 20 patients were excluded due to drop out prior to completion (5 patients) and absence of blood examination results (15 patients). The remaining 39 patients met the inclusion criteria and were included in the analysis.
Adverse events
none
Outcome measures
Laboratory tests at baseline included overnight fasting measurements of aspartate aminotransferase, ALT, g glutamyltranspeptidase, total cholesterol, triglyceride, high-density lipoprotein cholesterol, fasting plasma glucose, HbA1c, immunoreactive insulin (IRI), ferritin, hyaluronic acid, type IV collagen 7S and type III procollagen N peptide. These parameters were measured by the standard techniques used in clinical chemistry laboratories (SRL, Tokyo, Japan). One year after registration, IRI, ferritin and type IV collagen 7S levels were obtained for the estimation of NAFIC scores. HbA1c levels were expressed in accordance with the National Glycohemoglobin Standardization Program, as recommended by the JDS.
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
| 2016 | Year | 01 | Month | 26 | Day |
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
| 2026 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009504
