UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009704
Receipt number 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 09:07:08

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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 or person

Institute

Chiba University

Institute

Department

Personal name



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

Value
https://center6.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