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

NCT ID: NCT04326244

Last Updated: 2020-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-10

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea Obesity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

blood test

Intervention Type DIAGNOSTIC_TEST

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

genetic test

Intervention Type DIAGNOSTIC_TEST

FTO、MC4R、BDNF、PPARG、ADRB3、UCP1

Constitution in Chinese Medicine Questionnaire

Intervention Type DIAGNOSTIC_TEST

Constitution in Chinese Medicine Questionnaire

Epworth Sleepiness Scale

Intervention Type DIAGNOSTIC_TEST

Epworth Sleepiness Scale

cephalometry

Intervention Type DIAGNOSTIC_TEST

Evaluation of craniofacial morphology in OSA patients

polysomnography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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blood test

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

Intervention Type DIAGNOSTIC_TEST

genetic test

FTO、MC4R、BDNF、PPARG、ADRB3、UCP1

Intervention Type DIAGNOSTIC_TEST

Constitution in Chinese Medicine Questionnaire

Constitution in Chinese Medicine Questionnaire

Intervention Type DIAGNOSTIC_TEST

Epworth Sleepiness Scale

Epworth Sleepiness Scale

Intervention Type DIAGNOSTIC_TEST

cephalometry

Evaluation of craniofacial morphology in OSA patients

Intervention Type DIAGNOSTIC_TEST

polysomnography

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kun-Hao Jiang

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial hospital

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yi-Hsuan Lin

Role: CONTACT

+886975366091

Facility Contacts

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Yi-Hsuan Lin

Role: primary

886-975366091

References

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Bielicki P, Plywaczewski R, Brzoska 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.

Reference Type BACKGROUND
PMID: 30600310 (View on PubMed)

Shah F, Forsgren S, Holmlund T, Levring Jaghagen E, Berggren D, Franklin KA, Stal 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.

Reference Type BACKGROUND
PMID: 30828636 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31044373 (View on PubMed)

Pierola J, Barcelo A, de la Pena M, Barbe F, Soriano JB, Sanchez Armengol A, Martinez C, Agusti A. beta3-Adrenergic receptor Trp64Arg polymorphism and increased body mass index in sleep apnoea. Eur Respir J. 2007 Oct;30(4):743-7. doi: 10.1183/09031936.00152006. Epub 2007 Jul 11.

Reference Type BACKGROUND
PMID: 17626108 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19079260 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28013339 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28539834 (View on PubMed)

Other Identifiers

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CMRPG1H0052

Identifier Type: -

Identifier Source: org_study_id

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