UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046994 |
|---|---|
| Receipt number | R000053615 |
| Scientific Title | Effect of oral semaglutide on hepatic fibrosis of type 2 diabetes patients with NAFLD |
| Date of disclosure of the study information | 2022/03/03 |
| Last modified on | 2024/02/26 11:00:41 |
* 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
Effect of oral semaglutide on hepatic fibrosis of type 2 diabetes patients with NAFLD
Acronym
Effect of oral semaglutide on hepatic fibrosis of type 2 diabetes patients with NAFLD
Scientific Title
Effect of oral semaglutide on hepatic fibrosis of type 2 diabetes patients with NAFLD
Scientific Title:Acronym
Effect of oral semaglutide on hepatic fibrosis of type 2 diabetes patients with NAFLD
Region
| Japan |
Condition
Condition
type 2 diabetes patients with NAFLD
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of oral semaglutide on hepatic fibrosis,body composition,glycemic control and tryptophan metabolism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change in FIB4 index at 6 months from baseline
Key secondary outcomes
change in NFS,M2BPGi,tryptophan and tryptophan metabolites and the other various parameters at 6 months from baseline
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Patients with suspected NAFLD by abdominal echo
(2)BMI higher than 25 kg/m2
(3)Taking alcohol less than 30g/day(men) and 20g/day(women)
(4)Switching from DPP-4 inhibitor to oral semaglutide
(5)Patients who consented to this study
Key exclusion criteria
(1) Diabetes other than type 2 diabetes
(2) Taking thiazolidine drugs
(3) History of use of other GLP-1 receptor agonists
(4) Patients diagnosed with liver diseases other than NAFLD such as viral hepatitis and autoimmune hepatitis
(5) Allergies to semaglutide
(6) Diabetic ketoacidosis, diabetic coma or precoma, type 1 diabetes
(7) Serious conditions such as acute infections and surgery
(8) Patients judged to be inappropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhide |
| Middle name | |
| Last name | Inoue |
Organization
Shizuoka General Hospital
Division name
Center for Diabetes, Endocrinology and Metabolism
Zip code
420-8527
Address
4-27-1, Kita Ando Aoi-Ku , Shizuoka city
TEL
0542476111
tatsuhide-inoue@i.shizuoka-pho.jp
Public contact
Name of contact person
| 1st name | Rieko |
| Middle name | |
| Last name | Kosugi |
Organization
Shizuoka General Hospital
Division name
Center for Diabetes, Endocrinology and Metabolism,
Zip code
420-8527
Address
4-27-1 Kita Ando Aoi-Ku, Shizuoka city
TEL
0542476111
Homepage URL
fwkh7040spring@yahoo.co.jp
Sponsor or person
Institute
Shizuoka General Hospital, Center for Diabetes, Endocrinology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka General Hospital, Ethics Committee
Address
4-27-1 Kita Ando Aoi-Ku, Shizuoka city
Tel
0542476111
chiken-sougou@shizuoka-pho.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
| 2022 | Year | 03 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 02 | Month | 29 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 02 | Month | 24 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053615
