Clinical trial NCT04326244: The Relationship Between Obesity-related Molecular Typing and Traditional Chinese Medicine Constitution
Official title: The Relationship Between Obesity-related Molecular Typing and Traditional Chinese Medicine Constitution
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Obesity
Keywords: Obesity
Obstructive Sleep Apnea
Gene
Traditional Chinese medicine constitution
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: obesity patient with Obstructive sleep apnea

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.

Eligibility criteria: 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

Primary outcomes:
measure: Obesity-related gene profile
timeFrame: At enrollment
measure: Constitution in Chinese Medicine Questionnaire
timeFrame: At enrollment
Secondary outcomes:
measure: Epworth Sleepiness Scale
timeFrame: At enrollment
measure: Polysomnography
timeFrame: At enrollment
measure: Cephalometry
timeFrame: At enrollment
measure: Lipid profile (mg/dl)
timeFrame: At enrollment
measure: Serum leptin test (ng/mL)
timeFrame: At enrollment
measure: Glucose AC (mg/dL)
timeFrame: At enrollment
measure: HbA1C (Glycohemoglobin, %)
timeFrame: At enrollment
measure: Insulin (uU/mL)
timeFrame: At enrollment
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Kun-Hao Jiang
role: PRINCIPAL_INVESTIGATOR
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