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

NCT04326244 | Unknown DMC

• 1 other identifier: CMRPG1H0052
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Obesity

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Epworth Sleepiness Scale

  At enrollment

• Polysomnography

  At enrollment

• Cephalometry

  At enrollment

• Lipid profile (mg/dl)

  At enrollment

• Serum leptin test (ng/mL)

  At enrollment

Study Arms (1)

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; Diagnostic Test: genetic test; Diagnostic Test: Constitution in Chinese Medicine Questionnaire; Diagnostic Test: Epworth Sleepiness Scale; Diagnostic Test: cephalometry; Diagnostic Test: polysomnography

Interventions

blood test DIAGNOSTIC_TEST

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

Snoring obesity patient

genetic test DIAGNOSTIC_TEST

FTO、MC4R、BDNF、PPARG、ADRB3、UCP1

Snoring obesity patient

Constitution in Chinese Medicine Questionnaire DIAGNOSTIC_TEST

Constitution in Chinese Medicine Questionnaire

Snoring obesity patient

Epworth Sleepiness Scale DIAGNOSTIC_TEST

Epworth Sleepiness Scale

Snoring obesity patient

cephalometry DIAGNOSTIC_TEST

Evaluation of craniofacial morphology in OSA patients

Snoring obesity patient

polysomnography DIAGNOSTIC_TEST

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

Snoring obesity patient

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

obesity patient with Obstructive sleep apnea

You may qualify if:

• ≦BMI≦35 kg/m² and with snoring during sleeping
• y/o\<age\<65y/o with conscious clear
• no recognition impairment
• could accept blood test and questionnaire
• willing to sign Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial hospital

Taoyuan District, 330, Taiwan

RECRUITING

Related Publications (7)

• 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.

  PMID: 30600310 BACKGROUND

• 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.

  PMID: 30828636 BACKGROUND

• 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.

  PMID: 31044373 BACKGROUND

• 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.

  PMID: 17626108 BACKGROUND

• 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.

  PMID: 19079260 BACKGROUND

• 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.

  PMID: 28013339 BACKGROUND

• 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.

  PMID: 28539834 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity

Interventions

Hematologic Tests; Genetic Testing; Cephalometry; Polysomnography

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; Anthropometry; Physical Examination; Biometry; Epidemiologic Measurements; Public Health; Environment and Public Health; Monitoring, Physiologic

Study Officials

• Kun-Hao Jiang

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Hsuan Lin

CONTACT

+886975366091; cynthiajobo@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 30, 2020
• Study Start: April 10, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)