UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006670 |
|---|---|
| Receipt number | R000007878 |
| Scientific Title | Seasonal variation of endothelium-dependent flow-mediated vasodilation |
| Date of disclosure of the study information | 2011/11/04 |
| Last modified on | 2011/11/04 18:02:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Seasonal variation of endothelium-dependent flow-mediated vasodilation
Acronym
Seasonal variation of FMD
Scientific Title
Seasonal variation of endothelium-dependent flow-mediated vasodilation
Scientific Title:Acronym
Seasonal variation of FMD
Region
| Japan |
Condition
Condition
hypertension, diabetes, hyperlipidemia
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We try to investigate the climate change on FMD.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of FMD between warm season and cool season.
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients recruited from outpatients who regularly visited the Miyashita clinic in Shizuoka-city, Shizuoka, Japan because of hypertension, diabetes mellitus and hyperlipidemia.
Key exclusion criteria
Patients with severe illness.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromichi Kumagai |
Organization
University of Shizuoka
Division name
Clinical Nutrition
Zip code
Address
52-1 Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL
054-264-5567
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromichi Kumagai |
Organization
University of Shizuoka
Division name
Clinical Nutrition
Zip code
Address
52-1 Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL
054-264-5567
Homepage URL
kumagai@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Global Center of Excellence Program at Japanese Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Miyashita Clinic
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
宮下クリニック（静岡県）Miyashita Clinic (Shizuoka)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 04 | 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
FMD was significantly higher in the warm season than in the cool season when the measurements were performed in the same participants and the paired comparison was made.
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 | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 10 | Month | 01 | Day |
Other
Other related information
Mean resting brachial artery diameter was significantly larger in the warm season than in the cool season. The maximal post-deflation brachial artery diameter was also significantly larger in the warm season than in the cool season. FMD that was calculated from the resting diameter and the maximal diameter was significantly higher in the warm season than in the cool season even if it was expressed as the relative value (%) or absolute value (mm). Twenty-one participants showed an increase of FMD in the warm season, although remained 6 participants exhibited paradoxical changes. No specific characteristics were found in these 6 participants.
The change of FMD value by the seasonal variation was not associated with gender, age, body mass index, smoking and alcohol consumption. There was no association between the seasonal change of FMD and the seasonal change of blood pressure in this study.
Management information
Registered date
| 2011 | Year | 11 | Month | 04 | Day |
Last modified on
| 2011 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007878
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
