UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014726
Receipt No. R000017118
Scientific Title Study on lipid absorption mechanism of the small intestine mucosa with small-bowel biopsy tissue
Date of disclosure of the study information 2014/07/31
Last modified on 2017/08/09

* 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 Study on lipid absorption mechanism of the small intestine mucosa with small-bowel biopsy tissue
Acronym Study on lipid absorption mechanism of the small intestine mucosa with small-bowel biopsy tissue
Scientific Title Study on lipid absorption mechanism of the small intestine mucosa with small-bowel biopsy tissue
Scientific Title:Acronym Study on lipid absorption mechanism of the small intestine mucosa with small-bowel biopsy tissue
Region
Japan

Condition
Condition non-alcoholic steatohepatitis
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 reveal the molecular mechanisms of the small intestine fatty acid absorption kinetics in the non-alcoholic
steatohepatitis patients
Basic objectives2 Others
Basic objectives -Others nothing
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes nothing
Key secondary outcomes

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Performing a biopsy from the upper jejunum with a small intestine endoscope
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Non-liver disease patients in need of
small intestinal endoscopy or endoscopic therapy

Non-alcoholic steatohepatitis patients
Key exclusion criteria Patients who can not understand the explanation(including a dementia)
50% or less PT, 50,000 or less platelets
Patients who can not undergo an endoscopic examination by poor general condition
Patients with chronic liver disease other than NASH
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Utsunomiya
Organization Ehime University Graduate School of Medicine
Division name Departments of Gastroenterology and Metabology
Zip code
Address Minamigata 1696-1 Rural 803, Toon, Ehime
TEL 08029725163
Email lopp_august@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Utsunomiya
Organization Ehime University Graduate School of Medicine
Division name Departments of Gastroenterology and Metabology
Zip code
Address Shitsukawa 454, Toon, Ehime
TEL 0899605308
Homepage URL
Email lopp_august@yahoo.co.jp

Sponsor
Institute Ehime University, Departments of Gastroenterology and Metabology
Institute
Department

Funding Source
Organization Departments of Gastroenterology and Metabology
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

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 31 Day

Related information
URL releasing protocol https://link.springer.com/article/10.1007%2Fs00535-016-1298-6
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/28062946
Number of participants that the trial has enrolled
Results
 Jejunal mRNA and protein expressions of microsomal triglyceride transfer protein and cluster of differentiation 36 were also increased in both NASH patient groups
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
2014 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2017 Year 08 Month 01 Day
Date of closure to data entry
2017 Year 08 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 31 Day
Last modified on
2017 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017118

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.