The Relationship Between Obesity-related Molecular Typing and Traditional Chinese Medicine Constitution
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Snoring obesity patient 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 |
Diagnostic Test: blood test
High-density lipoprotein- cholesterol, Low-density lipoprotein- cholesterol, Total cholesterol, Triglyceride, Leptin, Glucose AC, Hemoglobin A1C, Insulin
Diagnostic Test: genetic test
FTO、MC4R、BDNF、PPARG、ADRB3、UCP1
Diagnostic Test: Constitution in Chinese Medicine Questionnaire
Constitution in Chinese Medicine Questionnaire
Diagnostic Test: Epworth Sleepiness Scale
Epworth Sleepiness Scale
Diagnostic Test: cephalometry
Evaluation of craniofacial morphology in OSA patients
Diagnostic Test: polysomnography
to evaluate Apnea-Hypopnea Index (AHI) for the severity of sleep apnea
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Glucose AC (mg/dL) [At enrollment]
High glucose AC is related to diabetes.
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chang Gung Memorial hospital | Taoyuan | Taiwan | 330 |
Sponsors and Collaborators
- Chang Gung Memorial Hospital
Investigators
- Principal Investigator: Kun-Hao Jiang, Chang Gung Memorial Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Bielicki P, Pływaczewski R, Brzóska K, Kumor M, Barnaś M, Jonczak L, Stępkowski TM, Piechuta A, Chazan R, Śliwiński P, Kruszewski M. Impact of polymorphism of selected genes on the diagnosis of type 2 diabetes in patients with obstructive sleep apnea. Pol Arch Intern Med. 2019 Jan 31;129(1):6-11. doi: 10.20452/pamw.4406. Epub 2018 Dec 29.
- Jiao X, Yang S, Yang Y, Li J, Sun H, Zhang M, Yang Y, Qin Y. Targeted sequencing analysis of PPARG identifies a risk variant associated with obstructive sleep apnea in Chinese Han subjects. Sleep Breath. 2020 Mar;24(1):167-174. doi: 10.1007/s11325-019-01855-x. Epub 2019 May 2.
- Piérola J, Barceló A, de la Peña M, Barbé F, Soriano JB, Sánchez Armengol A, Martínez C, Agustí A. beta3-Adrenergic receptor Trp64Arg polymorphism and increased body mass index in sleep apnoea. Eur Respir J. 2007 Oct;30(4):743-7. Epub 2007 Jul 11.
- Shah F, Forsgren S, Holmlund T, Levring Jäghagen E, Berggren D, Franklin KA, Stål P. Neurotrophic factor BDNF is upregulated in soft palate muscles of snorers and sleep apnea patients. Laryngoscope Investig Otolaryngol. 2018 Nov 28;4(1):174-180. doi: 10.1002/lio2.225. eCollection 2019 Feb.
- Thorleifsson G, Walters GB, Gudbjartsson DF, Steinthorsdottir V, Sulem P, Helgadottir A, Styrkarsdottir U, Gretarsdottir S, Thorlacius S, Jonsdottir I, Jonsdottir T, Olafsdottir EJ, Olafsdottir GH, Jonsson T, Jonsson F, Borch-Johnsen K, Hansen T, Andersen G, Jorgensen T, Lauritzen T, Aben KK, Verbeek AL, Roeleveld N, Kampman E, Yanek LR, Becker LC, Tryggvadottir L, Rafnar T, Becker DM, Gulcher J, Kiemeney LA, Pedersen O, Kong A, Thorsteinsdottir U, Stefansson K. Genome-wide association yields new sequence variants at seven loci that associate with measures of obesity. Nat Genet. 2009 Jan;41(1):18-24. doi: 10.1038/ng.274. Epub 2008 Dec 14.
- Yang Q, Xiao T, Guo J, Su Z. Complex Relationship between Obesity and the Fat Mass and Obesity Locus. Int J Biol Sci. 2017 May 15;13(5):615-629. doi: 10.7150/ijbs.17051. eCollection 2017. Review.
- Yeo GSH. Genetics of obesity: can an old dog teach us new tricks? Diabetologia. 2017 May;60(5):778-783. doi: 10.1007/s00125-016-4187-x. Epub 2016 Dec 24. Review.
- CMRPG1H0052