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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030282
Receipt No. R000034261
Scientific Title A Randomized, Multi-center Trial for the Effects of Dietary Instruction on Cardiovascular Risk Markers after Smoking Cessation
Date of disclosure of the study information 2017/12/06
Last modified on 2019/06/28

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Basic information
Public title A Randomized, Multi-center Trial for the Effects of Dietary Instruction on Cardiovascular Risk Markers after Smoking Cessation
Acronym Trial for the Effects of Dietary Instruction on Cardiovascular Risk Markers after Smoking Cessation
Scientific Title A Randomized, Multi-center Trial for the Effects of Dietary Instruction on Cardiovascular Risk Markers after Smoking Cessation
Scientific Title:Acronym Trial for the Effects of Dietary Instruction on Cardiovascular Risk Markers after Smoking Cessation
Region
Japan

Condition
Condition nicotine dependency
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the prevention effect of nutritional guidance on obesity after smoking cessation
Basic objectives2 Others
Basic objectives -Others Glucose and lipid metabolism,
Cardiovascular risk markers,
Continuous abstinence rate from smoking
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Cardiovascular risk marker: AT-LDL, SAA-LDL, high sensitivity CRP, LOX index, adiponectin
Key secondary outcomes Glucose and lipid metabolism (HbA1c, LDL-C, HDL-C, non-HDL-C, leptin),
body weight (BMI) and waist circumference,
continuous abstinence rate from smoking

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 YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group
An intervention period: Nine months
Nourishment instruction: Three times (once in three months).
Interventions/Control_2 Non Intervention group
An intervention period: Nine months
Nourishment instruction: None
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria (1)Patients who succeed in smoking cessation at the time of the fifth visit (Definition of success in smoking cessation: expired carbon monoxide concentration of less than 7 ppm and the patient affirmation of no smoking for one week (2)Patients within one month from the fifth visit (3)Patients with weight gain more than 1kg from the first visit to the fifth visit to smoking cessation clinic (4)Pacients who gave informed written consent
Key exclusion criteria (1)Patients who receive nourishment instruction regularly
(2)Patients in an unfavorable state for nourishment instruction enforcement (e.g., shock state, serious infectious disease,acute phase of cerebral infarction or myocardial infarction, terminal stage of cancer, remarkabe gastrointestinal weakness)
(3)Pregnancy or breastfeeding patients
(4)Patients who take steroid regularly
(5)Patients with uncontrolled diabetes mellitus (with HbA1c level more than 10.0%)
(5)Patients who are judged to be unsuitable to paticipate in this clinical trial by a doctor (e,g,. patients with advanced dementia)
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Koji
Middle name
Last name Hasegawa
Organization National Hospital Organization Kyoto
Medical Center
Division name Division of Translational Research
Zip code 6128555
Address 1-1 Mukaihata-cho, Fukakusa, Fushimiku,kyoto citiy
TEL 075-641-9161
Email nikonikomakirin@yahoo.co.jp

Public contact
Name of contact person
1st name Koji
Middle name
Last name Hasegawa
Organization National Hospital Organization Kyoto Medical Center
Division name Division of Translational Research
Zip code 6128555
Address 1-1 Mukaihata-cho, Fukakusa, Fushimiku,kyoto citiy
TEL 075-641-9161
Homepage URL
Email koj@kuhp.kyoto-u.ac.jp

Sponsor
Institute National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization operating support funds
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 National Hospital Organization Kyoto Medical Center
Address 1-1 Mukaihata-cho, Fukakusa, Fushimiku,kyoto citiy
Tel 075-641-9161
Email timutimu0712@gmail.com

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
2017 Year 12 Month 06 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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 20 Day
Date of IRB
2017 Year 06 Month 20 Day
Anticipated trial start date
2017 Year 09 Month 06 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 06 Day
Last modified on
2019 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034261

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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