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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009704
Receipt No. R000011376
Scientific Title Analysis of GLP-1 in the FD patients with mosapride treatment
Date of disclosure of the study information 2013/01/06
Last modified on 2014/08/07

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Basic information
Public title Analysis of GLP-1 in the FD patients with mosapride treatment
Acronym Analysis of GLP-1 in mosapride treatment
Scientific Title Analysis of GLP-1 in the FD patients with mosapride treatment
Scientific Title:Acronym Analysis of GLP-1 in mosapride treatment
Region
Japan

Condition
Condition Functional dyspepsia
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the new function of Mpsapride
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes GLP-1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria FD with mosapride treatment
Key exclusion criteria It depends on physicians judgement
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Arai
Organization Chiba University
Division name Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba City
TEL 043-222-7171
Email araim-cib@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Arai
Organization Chiba University
Division name Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba City, JAPAN
TEL 043-226-2083
Homepage URL
Email araim-cib@umin.ac.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Chiba University
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
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
2013 Year 01 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25008428
Number of participants that the trial has enrolled
Results
RESULTS:
In human subjects, postprandial plasma active glucagon-like peptide-1 and serum insulin concentrations after administration of mosapride citrate were significantly higher than those pre-administration . The mouse expression levels of T1r2 and Gnat3 in the proximal jejunum and mid-jejunum in the M group (4.1-fold, 3.1-fold, and 4.6-fold, 3.1-fold increases, respectively), were significantly higher than those of the control group.
CONCLUSIONS:

The administration of mosapride citrate for 2 weeks enhanced postprandial plasma active glucagon-like peptide-1 and serum insulin concentration and increased the expression of sweet taste receptors in the upper intestine.
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
2012 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluating GLP-1 value in the patinets with mosapride treatment

Management information
Registered date
2013 Year 01 Month 06 Day
Last modified on
2014 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011376

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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