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 |
A Randomized, Multi-center Trial for the Effects of Dietary Instruction on Cardiovascular Risk Markers after Smoking Cessation
Trial for the Effects of Dietary Instruction on Cardiovascular Risk Markers after Smoking Cessation
A Randomized, Multi-center Trial for the Effects of Dietary Instruction on Cardiovascular Risk Markers after Smoking Cessation
Trial for the Effects of Dietary Instruction on Cardiovascular Risk Markers after Smoking Cessation
Japan |
nicotine dependency
Medicine in general | Cardiology |
Others
NO
To verify the prevention effect of nutritional guidance on obesity after smoking cessation
Others
Glucose and lipid metabolism,
Cardiovascular risk markers,
Continuous abstinence rate from smoking
Confirmatory
Pragmatic
Cardiovascular risk marker: AT-LDL, SAA-LDL, high sensitivity CRP, LOX index, adiponectin
Glucose and lipid metabolism (HbA1c, LDL-C, HDL-C, non-HDL-C, leptin),
body weight (BMI) and waist circumference,
continuous abstinence rate from smoking
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
2
Treatment
Behavior,custom |
Intervention group
An intervention period: Nine months
Nourishment instruction: Three times (once in three months).
Non Intervention group
An intervention period: Nine months
Nourishment instruction: None
20 | years-old | <= |
80 | years-old | > |
Male and Female
(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
(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)
250
1st name | Koji |
Middle name | |
Last name | Hasegawa |
National Hospital Organization Kyoto
Medical Center
Division of Translational Research
6128555
1-1 Mukaihata-cho, Fukakusa, Fushimiku,kyoto citiy
075-641-9161
nikonikomakirin@yahoo.co.jp
1st name | Koji |
Middle name | |
Last name | Hasegawa |
National Hospital Organization Kyoto Medical Center
Division of Translational Research
6128555
1-1 Mukaihata-cho, Fukakusa, Fushimiku,kyoto citiy
075-641-9161
koj@kuhp.kyoto-u.ac.jp
National Hospital Organization Kyoto Medical Center
National Hospital Organization operating support funds
Other
National Hospital Organization Kyoto Medical Center
1-1 Mukaihata-cho, Fukakusa, Fushimiku,kyoto citiy
075-641-9161
timutimu0712@gmail.com
NO
2017 | Year | 12 | Month | 06 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 06 | Month | 20 | Day |
2017 | Year | 06 | Month | 20 | Day |
2017 | Year | 09 | Month | 06 | Day |
2022 | Year | 03 | Month | 31 | Day |
2017 | Year | 12 | Month | 06 | Day |
2019 | Year | 06 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034261
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