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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002996
Receipt No. R000003632
Scientific Title Assessment of diabetic gastroparesis.
Date of disclosure of the study information 2010/01/08
Last modified on 2014/01/08

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Basic information
Public title Assessment of diabetic gastroparesis.
Acronym Assessment of diabetic gastroparesis.
Scientific Title Assessment of diabetic gastroparesis.
Scientific Title:Acronym Assessment of diabetic gastroparesis.
Region
Japan

Condition
Condition Diabetic gastroparesis
Classification by specialty
Gastroenterology Endocrinology and Metabolism Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment of digestive moving function using scintigraphic study of gastric emptying about diabetic gastroparesis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Gastric emptying time
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients are enrolled in the study if they meet both of the following criteria.
1:Patients who have diabetes mellitus and start insulin therapy newly.
2:Written informed consent.
Key exclusion criteria 1:Severe liver or renal dysfunction
2:Pregnancy, nurse
3:Patients who had infectious disease within two weeks
4:Patients who have other disease
5:Patients who are diqualified the study by their physicians
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Shiomi
Organization Osaka City University Graduate School of Medicine
Division name Nuclear Medicine
Zip code
Address 1-4-3 Asahimachi, Abeno-ku, Osaka City
TEL 06-6645-3885
Email shiomis@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Etsushi Kawamura
Organization Osaka City University Hospital
Division name Nuclear Medicine
Zip code
Address 1-4-3 Asahimachi, Abeno-ku, Osaka City
TEL 06-6645-3885
Homepage URL
Email etsushi-k@med.osaka-cu.ac.jp

Sponsor
Institute Nuclear Medicine, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nuclear Medicine, Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Metabolism, Endocrinology, and Molecular Medicine, Osaka City University Graduate School of Medicine
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
2010 Year 01 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Vascular disorder, among other cofactors such as autonomic neuropathy, could be involved in the pathophysiology of delayed gastric emptying.
(Clin Physiol Funct Imaging. 2013 Aug 18. doi: 10.1111/cpf.12079.)
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
2009 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2012 Year 01 Month 01 Day
Date of closure to data entry
2012 Year 02 Month 01 Day
Date trial data considered complete
2012 Year 04 Month 01 Day
Date analysis concluded
2012 Year 05 Month 01 Day

Other
Other related information Digestive moving function about diabetes mellitus.

Management information
Registered date
2010 Year 01 Month 08 Day
Last modified on
2014 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003632

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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