UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002996 |
|---|---|
| Receipt number | R000003632 |
| Scientific Title | Assessment of diabetic gastroparesis. |
| Date of disclosure of the study information | 2010/01/08 |
| Last modified on | 2014/01/08 09:12:50 |
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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
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
etsushi-k@med.osaka-cu.ac.jp
Sponsor or person
Institute
Nuclear Medicine, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003632
