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Clinical Trials/NCT04326244
NCT04326244
Unknown
Not Applicable

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

Chang Gung Memorial Hospital1 site in 1 country50 target enrollmentApril 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
Chang Gung Memorial Hospital
Enrollment
50
Locations
1
Primary Endpoint
Obesity-related gene profile
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 10, 2020
End Date
December 31, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Obesity-related gene profile

Time Frame: 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

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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