UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045508 |
|---|---|
| Receipt number | R000051959 |
| Scientific Title | Clinical study of ileal bile acid transporter inhibitor on changes in bowel movements and various metabolic markers in type 2 diabetic patients |
| Date of disclosure of the study information | 2021/09/17 |
| Last modified on | 2021/09/17 16:52:46 |
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Basic information
Public title
Clinical study of ileal bile acid transporter inhibitor on changes in bowel movements and various metabolic markers in type 2 diabetic patients
Acronym
Clinical study of ileal bile acid transporter inhibitor on changes in bowel movements and various metabolic markers in type 2 diabetic patients
Scientific Title
Clinical study of ileal bile acid transporter inhibitor on changes in bowel movements and various metabolic markers in type 2 diabetic patients
Scientific Title:Acronym
Clinical study of ileal bile acid transporter inhibitor on changes in bowel movements and various metabolic markers in type 2 diabetic patients
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of elobixibat on defecation and various metabolic markers in type 2 diabetic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bowel movements (frequency of bowel movements, Bristol Scale)
Key secondary outcomes
Blood glucose,HbA1c,LDL,HDL,triglyceride,fatty acid fraction,AST,ALT,gammaGTP,Total bile acid,TSH,FT3,FT4,CRP,UA, Ferritin,body weight
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
10mg elobixibat treatment for 12 weeks
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
Diagnosis of chronic constipation as defined by Rome IV criteria.
Type 2 diabetes with HbA1c less than 10%.
20 years of age or older.
Patient who can provide written informed consent before enrollment.
Patient who had received a stable antidiabetic regimen for at least 3 months prior to study entry.
Patient who can obtain blood and urine samples for follow-up before and after the eloboxibat treatment.
Key exclusion criteria
Pregnant or lactating women
Patient with intestinal obstruction due to tumor or hernia etc.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Yoshinobu |
Organization
Kurume University School of Medicine
Division name
Department of Internal Medicine, Division of Endocrinology and Metabolism
Zip code
8300011
Address
67 Asahi-machi, Kurume city Fukuoka, JAPAN
TEL
0942317563
yoshinobu_satoko@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Yoshinobu |
Organization
Kurume University School of Medicine
Division name
Department of Internal Medicine, Division of Endocrinology and Metabolism
Zip code
8300011
Address
67 Asahi-machi, Kurume city Fukuoka, JAPAN
TEL
0942317563
Homepage URL
yoshinobu_satoko@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
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
Industry-Academia-Government Collaboration Office, Kurume University
Address
67 Asahi-machi, Kurume city Fukuoka, JAPAN
Tel
0942317563
sangaku@kurume-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
久留米大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 17 | 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
21
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
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2020 | 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
| 2021 | Year | 09 | Month | 17 | Day |
Last modified on
| 2021 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051959
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
