UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010947 |
|---|---|
| Receipt number | R000012813 |
| Scientific Title | The effect of colestimide on metabolic parameters |
| Date of disclosure of the study information | 2013/06/13 |
| Last modified on | 2013/06/13 00:07:22 |
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Basic information
Public title
The effect of colestimide on metabolic parameters
Acronym
The effect of colestimide on metabolic parameters
Scientific Title
The effect of colestimide on metabolic parameters
Scientific Title:Acronym
The effect of colestimide on metabolic parameters
Region
| Japan |
Condition
Condition
diabetes and metabolic syndrome
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the effect of colestimide on metabolic parameters
Basic objectives2
Others
Basic objectives -Others
To clarify the effects of resins on metabolic parameters
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the effects of colestimide in diabetes and metabolic syndrome
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with diabetes or metabolic syndromes
Key exclusion criteria
Patients who cannot finish the protocol
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Itoh |
Organization
Keio Univeristy School of Medicine
Division name
Nephrology, Endocrinology and Metabolism
Zip code
Address
35 shinanomachi, Shinjuku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio Univeristy School of Medicine
Division name
Nephrology, Endocrinology and Metabolism
Zip code
Address
35 shinanomachi, Shinjuku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
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
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
慶應義塾大学病院（東京都）
Keio University Hospital (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
| 2013 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Body weight, metabolic parameter and treatment
Management information
Registered date
| 2013 | Year | 06 | Month | 13 | Day |
Last modified on
| 2013 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012813
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
