UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030282
Receipt number 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 14:52:03

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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 or person

Institute

National Hospital Organization Kyoto Medical Center

Institute

Department

Personal name



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

Value
https://center6.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