The Relationship Between Obesity-related Molecular Typing and Traditional Chinese Medicine Constitution
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Obesity-related gene profile
研究概览
简要总结
Obesity is an epidemic and a growing problem in the world. There are numerous causes of obesity, the most novel and personalized of which is genetic inheritance. Single nucleotide polymorphisms are the most common type of genetic variation among people, regulating the response between the diet and the body. Meanwhile, Traditional Chinese medicine pattern differentiation is also personalized and usually influenced by inheritance, living habits, character and environment and so on. The common constitutions in obesity are Qi deficiency, Yang Deficiency, and Phlegm dampness, which are correlated with oxygen, sugar and fat metabolism, also affected by gene expression. Therefore, the relationship between constitution, metabolism and genetic molecular typing may be significant in obesity with obstructive sleep apnea patients.
详细描述
Method The adults whose age between 20~65 years old, BMI between 27kg/m² and 35kg/m², and also have snoring during sleeping are able to be enrolled in the study. Then, the general data questionnaire, Body Constitution Questionnaire, physical examination, blood test, and genetic test are provided to subjects. The blood test includes High-density lipoprotein- cholesterol, Low-density lipoprotein- cholesterol, Total cholesterol, Triglyceride, Leptin, Glucose AC, Hemoglobin A1C, Insulin; the DNA test includes FTO、MC4R、BDNF、PPARG、ADRB3、UCP1. Epworth Sleepiness Scale, laryngoscope and polysomnography are also performed in the patients enrolled. The Traditional Chinese medicine constitution can be classified and its relationship between different figure types, serum lipid level as well as obesity-related gene can be analyzed. The results will be described after a statistical analysis.
Aim The aim of this study is to analyze the constitution, finding the association between obesity patients with obstructive sleep apnea and their related molecular typing and Traditional Chinese Medicine constitution.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •27≦BMI≦35 kg/m² and with snoring during sleeping
- •20y/o<age<65y/o with conscious clear
- •no recognition impairment
- •could accept blood test and questionnaire
- •willing to sign Informed consent
排除标准
- •age<20 years old
- •pregnancy or women under breastfeeding
- •patients have been diagnosed with endocrine disorders such as thyroid, adrenal and autoimmune disease
- •patients have been diagnosed with neurological or psychological disorders with recognition impairment
- •Patients with severe visual, hearing, or physical impairment that would interfere with questionnaire processing.
- •Patients are under other experimental medication
- •Patients are under weight-loss drug in recent one month
结局指标
主要结局
Obesity-related gene profile
时间窗: At enrollment
Examine Obesity-related gene profile: FTO, MC4R, BDNF, PPARG, ADRB3, UCP1 to evaluate the association between gene profile and obstructive sleep apnea (OSA) or traditional Chinese medicine (TCM) constitution.
Constitution in Chinese Medicine Questionnaire
时间窗: At enrollment
The scale classification of the patient's constitution according to Traditional Chinese Medicine theory into nine constitutions. The Constitution in Chinese Medicine Questionnaire (CCMQ) consists of 60 items to classify a person into one or more of nine body constitution types: balanced (8 Items), Qi-deficiency (8 Items), Yang-deficiency (7 Items), Yin-deficiency (8 Items), phlegm-wetness (8 Items), wetness-heat (6 Items), blood-stasis (7 Items), Qi-depression (7 Items), and special diathesis (7 Items). A higher score in the CCMQ scale indicates a higher likelihood of the specific body constitution. The original score is sum up each item's score. The converted scores is \[(original scores- items)/(items\*40\]\*100. The balanced constitution is the converted score \>60 and the rest constitutions' converted scores all \< 30. The unbalanced constitution is the converted score ≥40.
次要结局
- Glucose AC (mg/dL)(At enrollment)
- Epworth Sleepiness Scale(At enrollment)
- Polysomnography(At enrollment)
- Cephalometry(At enrollment)
- Lipid profile (mg/dl)(At enrollment)
- Serum leptin test (ng/mL)(At enrollment)
- HbA1C (Glycohemoglobin, %)(At enrollment)
- Insulin (uU/mL)(At enrollment)