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

July 14, 2020 updated by: Chang Gung Memorial Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 330
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

obesity patient with Obstructive sleep apnea

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At enrollment
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.
At enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epworth Sleepiness Scale
Time Frame: 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.
At enrollment
Polysomnography
Time Frame: At enrollment
The evaluation on obstructive sleep apnea severity
At enrollment
Cephalometry
Time Frame: At enrollment
The evaluation on cranial morphology of enrolled patients
At enrollment
Lipid profile (mg/dl)
Time Frame: At enrollment
Includes High-density lipoprotein- cholesterol, Low-density lipoprotein- cholesterol, Total cholesterol, Triglyceride.
At enrollment
Serum leptin test (ng/mL)
Time Frame: At enrollment
High serum leptin level is related to obesity
At enrollment
Glucose AC (mg/dL)
Time Frame: At enrollment
High glucose AC is related to diabetes.
At enrollment
HbA1C (Glycohemoglobin, %)
Time Frame: At enrollment
High HbA1C is related to diabetes.
At enrollment
Insulin (uU/mL)
Time Frame: 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.
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Kun-Hao Jiang, Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2020

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRPG1H0052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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