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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04326244
• Other study ID #: CMRPG1H0052
• Status: Recruiting
• Start date: April 10, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: Chang Gung Memorial Hospital
• Contact: Yi-Hsuan Lin
• Phone: +886975366091
• Email: cynthiajobo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• blood test
High-density lipoprotein- cholesterol, Low-density lipoprotein- cholesterol, Total cholesterol, Triglyceride, Leptin, Glucose AC, Hemoglobin A1C, Insulin
• genetic test
FTO?MC4R?BDNF?PPARG?ADRB3?UCP1
• Constitution in Chinese Medicine Questionnaire
Constitution in Chinese Medicine Questionnaire
• Epworth Sleepiness Scale
Epworth Sleepiness Scale
• cephalometry
Evaluation of craniofacial morphology in OSA patients
• polysomnography
to evaluate Apnea-Hypopnea Index (AHI) for the severity of sleep apnea

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

Bielicki P, Plywaczewski R, Brzóska K, Kumor M, Barnas M, Jonczak L, Stepkowski TM, Piechuta A, Chazan R, Sliwinski 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obesity-related gene profile	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.	At enrollment
Primary	Constitution in Chinese Medicine Questionnaire	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.	At enrollment
Secondary	Epworth Sleepiness Scale	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.	At enrollment
Secondary	Polysomnography	The evaluation on obstructive sleep apnea severity	At enrollment
Secondary	Cephalometry	The evaluation on cranial morphology of enrolled patients	At enrollment
Secondary	Lipid profile (mg/dl)	Includes High-density lipoprotein- cholesterol, Low-density lipoprotein- cholesterol, Total cholesterol, Triglyceride.	At enrollment
Secondary	Serum leptin test (ng/mL)	High serum leptin level is related to obesity	At enrollment
Secondary	Glucose AC (mg/dL)	High glucose AC is related to diabetes.	At enrollment
Secondary	HbA1C (Glycohemoglobin, %)	High HbA1C is related to diabetes.	At enrollment
Secondary	Insulin (uU/mL)	HOMA-IR index (Homeostasis Model Assessment-Insulin Resistance index) is calculated by Insulin with Glucose AC to evaluate the insulin resistance of enrolled patients.	At enrollment