The Relationship Between Obesity-related Molecular Typing and Traditional Chinese Medicine Constitution

• Conditions: Obesity; Obstructive Sleep Apnea
• Interventions: Diagnostic Test: blood test; Diagnostic Test: genetic test; Diagnostic Test: Constitution in Chinese Medicine Questionnaire; Diagnostic Test: Epworth Sleepiness Scale; Diagnostic Test: cephalometry; Diagnostic Test: polysomnography

• Registration Number: NCT04326244
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-30
• Study Start: 2020-04-10
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-15
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. 27≦BMI≦35 kg/m² and with snoring during sleeping
2. 20y/o<age<65y/o with conscious clear
3. no recognition impairment
4. could accept blood test and questionnaire
5. willing to sign Informed consent

Exclusion Criteria

1. age<20 years old
2. pregnancy or women under breastfeeding
3. patients have been diagnosed with endocrine disorders such as thyroid, adrenal and autoimmune disease
4. patients have been diagnosed with neurological or psychological disorders with recognition impairment
5. Patients with severe visual, hearing, or physical impairment that would interfere with questionnaire processing.
6. Patients are under other experimental medication
7. Patients are under weight-loss drug in recent one month

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Snoring obesity patient	blood test	Constitution in Chinese Medicine 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
Snoring obesity patient	cephalometry	Constitution in Chinese Medicine 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
Snoring obesity patient	polysomnography	Constitution in Chinese Medicine 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
Snoring obesity patient	genetic test	Constitution in Chinese Medicine 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
Snoring obesity patient	Constitution in Chinese Medicine Questionnaire	Constitution in Chinese Medicine 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
Snoring obesity patient	Epworth Sleepiness Scale	Constitution in Chinese Medicine 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

Primary Outcome Measures

Name	Time	Method
Obesity-related gene profile	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	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.

Secondary Outcome Measures

Name	Time	Method
Glucose AC (mg/dL)	At enrollment	High glucose AC is related to diabetes.
Epworth Sleepiness Scale	At enrollment	The severity evaluation of impact on lethargy caused by obstructive sleep apnea. The total score can range from 0 to 24. A higher score is associated with increased sleepiness.
Polysomnography	At enrollment	The evaluation on obstructive sleep apnea severity
Cephalometry	At enrollment	The evaluation on cranial morphology of enrolled patients
Lipid profile (mg/dl)	At enrollment	Includes High-density lipoprotein- cholesterol, Low-density lipoprotein- cholesterol, Total cholesterol, Triglyceride.
Serum leptin test (ng/mL)	At enrollment	High serum leptin level is related to obesity
HbA1C (Glycohemoglobin, %)	At enrollment	High HbA1C is related to diabetes.
Insulin (uU/mL)	At enrollment	HOMA-IR index (Homeostasis Model Assessment-Insulin Resistance index) is calculated by Insulin with Glucose AC to evaluate the insulin resistance of enrolled patients.

Trial Locations

Locations (1)

Chang Gung Memorial hospital; 🇨🇳 Taoyuan, Taiwan