UMIN-CTR Clinical Trial

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