UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021141 |
|---|---|
| Receipt number | R000024385 |
| Scientific Title | The Effect of Procyanidin on Endotherial Function |
| Date of disclosure of the study information | 2016/02/29 |
| Last modified on | 2018/09/28 09:02:10 |
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Basic information
Public title
The Effect of Procyanidin on Endotherial Function
Acronym
The Effect of Procyanidin on Endotherial Function
Scientific Title
The Effect of Procyanidin on Endotherial Function
Scientific Title:Acronym
The Effect of Procyanidin on Endotherial Function
Region
| Japan |
Condition
Condition
Impaired glucose tolerance
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of Procyanidin on endotherial function in patients with impaired glucose tolerance
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
flow mediated diation, blood pressure variability
Key secondary outcomes
HOMA-IR, QUICKI
HbA1c, 1,5-AG, Insulin, Glucose
AGEs, RAGE
Intercellular Adhesion Molecule 1(ICAM-1),Vascular Cell Adhesion
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Procyanidin
Interventions/Control_2
placebo
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
| 45 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
5.8<HbA1c<7.0
18.5<BMI<27.5
Key exclusion criteria
smoker
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuki Shiina |
Organization
Tokyo Medical University
Division name
Cardiology
Zip code
Address
6-7-1, Nishi-shinjuku, Shinjuku-ku,Tokyo, Japan
TEL
03-3342-6111
shiina@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuki Shiina |
Organization
Tokyo Medical University
Division name
Cardiology
Zip code
Address
6-7-1, Nishi-shinjuku, Shinjuku-ku,Tokyo, Japan
TEL
03-3342-6111
Homepage URL
shiina@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo medical University
Institute
Department
Personal name
Funding Source
Organization
Meiji
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 29 | 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
| 2015 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 22 | Day |
Last modified on
| 2018 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024385
| 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 |
