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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04326244
Enrollment
50
Registered
2020-03-30
Start date
2020-04-10
Completion date
2020-12-31
Last updated
2020-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Obesity

Keywords

Obesity, Obstructive Sleep Apnea, Gene, Traditional Chinese medicine constitution

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.

Interventions

DIAGNOSTIC_TESTblood test

High-density lipoprotein- cholesterol, Low-density lipoprotein- cholesterol, Total cholesterol, Triglyceride, Leptin, Glucose AC, Hemoglobin A1C, Insulin

DIAGNOSTIC_TESTgenetic test

FTO、MC4R、BDNF、PPARG、ADRB3、UCP1

Constitution in Chinese Medicine Questionnaire

Epworth Sleepiness Scale

DIAGNOSTIC_TESTcephalometry

Evaluation of craniofacial morphology in OSA patients

DIAGNOSTIC_TESTpolysomnography

to evaluate Apnea-Hypopnea Index (AHI) for the severity of sleep apnea

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Obesity-related gene profileAt enrollmentExamine 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 QuestionnaireAt enrollmentThe 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

MeasureTime frameDescription
CephalometryAt enrollmentThe evaluation on cranial morphology of enrolled patients
Lipid profile (mg/dl)At enrollmentIncludes High-density lipoprotein- cholesterol, Low-density lipoprotein- cholesterol, Total cholesterol, Triglyceride.
Serum leptin test (ng/mL)At enrollmentHigh serum leptin level is related to obesity
Epworth Sleepiness ScaleAt enrollmentThe 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.
HbA1C (Glycohemoglobin, %)At enrollmentHigh HbA1C is related to diabetes.
Insulin (uU/mL)At enrollmentHOMA-IR index (Homeostasis Model Assessment-Insulin Resistance index) is calculated by Insulin with Glucose AC to evaluate the insulin resistance of enrolled patients.
Glucose AC (mg/dL)At enrollmentHigh glucose AC is related to diabetes.
PolysomnographyAt enrollmentThe evaluation on obstructive sleep apnea severity

Countries

Taiwan

Contacts

Primary ContactYi-Hsuan Lin
cynthiajobo@gmail.com+886975366091

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026