Unique ID issued by UMIN | UMIN000044518 |
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Receipt number | R000050861 |
Scientific Title | A Study on Targeting the Rate of Change of Muscle-Adipose Tissue for the Prevention of Cardiovascular Disease |
Date of disclosure of the study information | 2021/06/13 |
Last modified on | 2021/06/13 00:03:30 |
A Study on Targeting the Rate of Change of Muscle-Adipose Tissue for the Prevention of Cardiovascular Disease
A Study on Targeting the Rate of Change of Muscle-Adipose Tissue for the Prevention of Cardiovascular Disease
A Study on Targeting the Rate of Change of Muscle-Adipose Tissue for the Prevention of Cardiovascular Disease
A Study on Targeting the Rate of Change of Muscle-Adipose Tissue for the Prevention of Cardiovascular Disease
Japan |
obesity
Sarcopenia
Cardiology | Endocrinology and Metabolism |
Others
NO
This study was conducted on patients with lifestyle-related diseases and no history of cardiovascular disease.
To examine the relationship between changes in skeletal muscle mass and body fat mass and factors associated with cardiovascular disease after 6 months of exercise, diet, and psychological intervention in patients.
Based on the results of the analysis, this study aims to set a target for the rate of change of skeletal muscle mass and body fat mass for the prevention of cardiovascular disease.
The primary endpoints of this study will be changes in skeletal muscle mass and body fat mass, and secondary endpoints will be body weight, blood pressure, glycolipid metabolic factors, adipokines, myokines, abdominal fat, arterial stiffness, physical fitness and physical activity, diet-related factors, and psychological indicators.
Efficacy
Exploratory
Explanatory
Not applicable
The primary endpoints of this study will be changes in skeletal muscle mass and body fat mass.
Secondary endpoints will be body weight, blood pressure, glycolipid metabolic factors, adipokines, myokines, abdominal fat, arterial stiffness, physical fitness and physical activity, diet-related factors, and psychological indicators.
Observational
20 | years-old | <= |
120 | years-old | >= |
Male and Female
Selection Criteria
Patients who meet all of the following criteria are eligible
(1) Patients aged 20 years or older at the time of obtaining consent
(2) Outpatient/inpatient: Any
(3) Gender: No question
(4) Patients who are able to use the physical activity meter used in this study
(5) Patients who have received sufficient explanations for participation in this study and have given their free consent with full understanding.
Exclusion criteria
Patients who violate any of the following will not be included in this study
(1) Patients with severe hepatic or renal dysfunction
(2) Pregnant or lactating women
3) Patients with a history of wasting disease or condition causing extreme weight loss (severe infection, invasive surgery, malignancy, severe trauma, hyperthyroidism, etc.) within the past 6 months
(4) Patients after implantation of pacemakers and implantable defibrillators
5) Patients with psychiatric disorders that are difficult to manage
(6) Patients who are unable to obtain written consent or who do not understand the outline and purpose of the research
(7) Patients who are judged by the principal investigator to be inappropriate as research subjects.
1000
1st name | yutaka |
Middle name | |
Last name | kimura |
Kansai Medical University
Health Science Center
573-1010
2-5-1 Shinmachi, Hirakata, Osaka
072-804-0101
kimuray@takii.kmu.ac.jp
1st name | Satoshi |
Middle name | |
Last name | Kurose |
Kansai Medical University
Health Science Center
573-1010
2-5-1 Shinmachi, Hirakata, Osaka
072-804-0101
kurosesa@hirakata.kmu.ac.jp
Kansai Medical University
Health Science Center
Japan Society for the Promotion of Science
Japanese Governmental office
Kansai Medical University Center for Ethical Review
2-5-1 Shinmachi, Hirakata, Osaka
072-804-2440
rinriirb@hirakata.kmu.ac.jp
NO
関西医科大学付属病院
2021 | Year | 06 | Month | 13 | Day |
Unpublished
Enrolling by invitation
2019 | Year | 09 | Month | 10 | Day |
2019 | Year | 10 | Month | 01 | Day |
2019 | Year | 10 | Month | 01 | Day |
2022 | Year | 03 | Month | 31 | Day |
Study type and design
Past and future starting cohort study
Research and survey items
The following items will be observed and examined, and the data will be used in this study. All of these items will be performed in routine medical care, and the frequency will be the same as in routine medical care. In the past-start cohort study, adipokines, myokines, and gene methylation rates will be assessed using blood specimens that are frozen and stored for secondary use in routine medical examinations and other studies.
1)Subject background: age, gender, diagnosis, medical history, height, weight, BMI, medication status, and lifestyle
2)Body composition: weight, BMI, skeletal muscle mass, body fat mass, limb skeletal muscle index, abdominal circumference
3)Blood tests: white blood cell, red blood cell, hemoglobin, lymphocyte count, total protein,albumin, AST, ALT
Creatinine, BUN, Na, K, Total cholesterol, HDL cholesterol, LDL cholesterol, TG, GLU, HbA1c, IRI, CRP, Adipokine, Myokine, TSH, FT4, FT3
4)Methylation rate of genes related to obesity
5)Urinalysis: protein, sugar, occult blood, urobilinogen
6)CT imaging: visceral fat area, subcutaneous fat area, body fat mass, lean mass, bone density
7)Arterial stiffness test: RHI, baPWV, ABI, systolic blood pressure, diastolic blood pressure, heart rate
8)Autonomic nervous system test: sympathetic nerve activity, parasympathetic nerve activity
9) Cardiac function test: electrocardiogram, echocardiography
10) Chest x-ray
11) Physical fitness assessment: grip strength, walking speed, isokinetic leg muscle strength, resting metabolism, anaerobic metabolic threshold, maximal oxygen uptake
12) Physical activity: number of steps, energy expenditure, life time assessment
2021 | Year | 06 | Month | 13 | Day |
2021 | Year | 06 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050861
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