UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006670
Receipt No. 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

* 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
Email

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
Email kumagai@u-shizuoka-ken.ac.jp

Sponsor
Institute University of Shizuoka
Institute
Department

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
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 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
URL(English) https://upload.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


Contact us.