UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033238 |
|---|---|
| Receipt number | R000037852 |
| Scientific Title | Effects of smoking cessation on the progression of arterial stiffness in postmenopausal women |
| Date of disclosure of the study information | 2018/07/06 |
| Last modified on | 2021/01/04 10:49:23 |
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Basic information
Public title
Effects of smoking cessation on the progression of arterial stiffness in postmenopausal women
Acronym
Effects of smoking cessation on the progression of arterial stiffness in postmenopausal women
Scientific Title
Effects of smoking cessation on the progression of arterial stiffness in postmenopausal women
Scientific Title:Acronym
Effects of smoking cessation on the progression of arterial stiffness in postmenopausal women
Region
| Japan |
Condition
Condition
arterial stiffness
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of smoking cessation on the progression of arterial stiffness in postmenopausal women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
brachial-ankle pulse wave velocity, 6 months, 12 months, 24 months after intervention
Key secondary outcomes
clinic blood pressure, home blood pressure, body composition, bone density, carbon monoxide
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Smoking cessation guidance(6 months), measurement(24 months)
Interventions/Control_2
Measurement only(24 months)
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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
Postmenopausal women
Current smoker
Key exclusion criteria
Outpatients visiting a clinin for smoking cessation
Use anti-smoking drug
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | masanori |
| Middle name | |
| Last name | munakata |
Organization
Research Center for the Promotion of Health and Employment Supports, Tohoku Rosai Hospital
Division name
Preventive medicine section
Zip code
981-8563
Address
3-21, Dainohara 4, Aoba-ku, Sendai-City, 981-8563, Japan
TEL
+81-22-275-1111
munakata@tohokuh.johas.go.jp
Public contact
Name of contact person
| 1st name | masanori |
| Middle name | |
| Last name | munakata |
Organization
Research Center for the Promotion of Health and Employment Supports, Tohoku Rosai Hospital
Division name
Preventive medicine section
Zip code
981-8563
Address
3-21, Dainohara 4, Aoba-ku, Sendai-City, 981-8563, Japan
TEL
+81-22-275-1111
Homepage URL
munakata@tohokuh.johas.go.jp
Sponsor or person
Institute
Research Center for the Promotion of Health and Employment Supports, Tohoku Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Organization of Occupational Health and Safety
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Center for the Promotion of Health and Employment Supports, Tohoku Rosai Hospital
Address
3-21, Dainohara 4, Aoba-ku, Sendai-City, 981-8563, Japan
Tel
+81-22-275-1111
utsumi@tohokuh.johas.go.jp
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
| 2018 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
https://www.tohokuh.johas.go.jp/others/prevention/gyoseki/img/seika_03.pdf
Publication of results
Unpublished
Result
URL related to results and publications
https://www.tohokuh.johas.go.jp/others/prevention/gyoseki/img/seika_03.pdf
Number of participants that the trial has enrolled
16
Results
In the intervention group, the number of smoking cigarettes tended to decrease, and both the exhaled carbon monoxide concentration and casual systolic blood pressure were decreased significantly while brachial-ankle remained unchanged. Only one person achieved smoking cessation. Stress at workplace or home and menopause-related symptoms were suggested as factors to obstruct smoking cessation. None of the measured unchanged in the control group.
Results date posted
| 2021 | Year | 01 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The 16 participants were 56.5 (6.7) years old.
Of the subjects analyzed, 6 in the intervention group were 54.7 (4.0) years and 6 in the control group were 58.3 (8.6) years.
Participant flow
Eight subjects were equally assigned to both groups but 2 subjects were drop-out from each group.
Adverse events
nothing
Outcome measures
1.Number of cigarettes smoked
Intervention group: 20.0 (13.3, 23.8), 10.0 (4.5, 20.0) after 6 months
Control group: 17.5 (5.8, 20.0), 17.5 (5.8, 20.0) after 6 months
*Data is median (25th, 75th)
2.Carbon monoxide concentration in exhaled breath (ppm)
Intervention group: 25.3 (20.6), 12.8 (14.8) after 6 months
Control group: 14.7 (9.0), 13.8 (11.1) after 6 months
3.Systolic blood pressure (mmHg)
Intervention group: 121.5 (17.3), 106.7 (15.0) after 6 months
Control group: 113.3 (12.2), 114.2 (9.0) after 6 months
*Data is average (SD)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 02 | Day |
Last modified on
| 2021 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037852
