UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055620 |
|---|---|
| Receipt number | R000063559 |
| Scientific Title | The relationship among fructose intake, length of duodenal villi and small intestinal permeability in the patients of metabolic dysfunction-associated steatoic liver disease |
| Date of disclosure of the study information | 2024/09/27 |
| Last modified on | 2024/09/25 17:54:50 |
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Basic information
Public title
The relationship among fructose intake, length of duodenal villi and small intestinal permeability in the patients of metabolic dysfunction-associated steatoic liver disease
Acronym
Fructose-MASLD study
Scientific Title
The relationship among fructose intake, length of duodenal villi and small intestinal permeability in the patients of metabolic dysfunction-associated steatoic liver disease
Scientific Title:Acronym
Fructose-MASLD study
Region
| Japan |
Condition
Condition
metabolic dysfuction-associated steatotic liver disease
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that excessive fuctose intake increases the duodenal villi length and calorie absorption effeiciency as a result, as well as increases small intestinal permeability and exposes hepatotoxic substances and bacteria to the liver through the portal vein, progressing to fatty liver, steatohepatitis, and cirrhosis
Basic objectives2
Others
Basic objectives -Others
To consider the relationship among fructose intake, length of duodenal villi and small intestinal permeability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fructose intake, length of duodenal villi, and small intestinal permeability
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) outpatient or hospitalized patients with MASLD, non-NAFLD liver disease, or without liver disease
2) patients who are scheduled to undergo an upper endoscopy for medical purposes within 3 months
3) patients who are able to take dietary questionnaires, duodenal biopsies, and intestinal permeability tests
4) patients giving voluntary written informed concent after sufficient explanation for participation in this study
Key exclusion criteria
1) Patients with abnormalities that are presumed to affect intestinal permeability, such as intestinal inflammation
2) Patients with a history of gastrointestinal surgery other than cholecystectomy or appendectomy
3) Patients with gastrointestinal malignancies
4) Patients with obvious bleeding tendencies or blood clotting abnormalities
5) Other patients who are judged to be inappropriate by the principal investigator or the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Matsushima |
Organization
Tokai University School of Medicine
Division name
Internal Medicine (gastroenterology)
Zip code
259-1193
Address
143 Shimokasuya, Isehara
TEL
0463931121
mmatsush@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Matsushima |
Organization
Tokai University School of Medicine
Division name
Internal Medicine (gastroenterology)
Zip code
259-1193
Address
143 Shimokasuya, Isehara
TEL
0463931121
Homepage URL
mmatsush@tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (Japan)
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
Research ethics committee, Tokai University School of Medicine
Address
143 Shimokasuya, Isehara
Tel
0463931121
tokai-rec@tokai.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing particular
Management information
Registered date
| 2024 | Year | 09 | Month | 25 | Day |
Last modified on
| 2024 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063559
