Obstructive Sleep ApneaNCT04326244
The Relationship Between Obesity-related Molecular Typing and Traditional Chinese Medicine Constitution
An observational study of Obstructive Sleep Apnea and Obesity, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea, Obesity
- What is being tested?
- blood test, genetic test and Constitution in Chinese Medicine Questionnaire
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Apr 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: obesity patient with Obstructive sleep apnea
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial hospital
Taoyuan, 330
Yi-Hsuan Lin, 886-975366091, cynthiajobo@gmail.com
About this study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Obesity
- Being tested
- blood test, genetic test, Constitution in Chinese Medicine Questionnaire, Epworth Sleepiness Scale, cephalometry
- Keywords
- Obesity, Obstructive Sleep Apnea, Gene, Traditional Chinese medicine constitution
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testDiagnostic test
High-density lipoprotein- cholesterol, Low-density lipoprotein- cholesterol, Total cholesterol, Triglyceride, Leptin, Glucose AC, Hemoglobin A1C, Insulin
genetic testDiagnostic test
FTO、MC4R、BDNF、PPARG、ADRB3、UCP1
Constitution in Chinese Medicine QuestionnaireDiagnostic test
Constitution in Chinese Medicine Questionnaire
Epworth Sleepiness ScaleDiagnostic test
Epworth Sleepiness Scale
cephalometryDiagnostic test
Evaluation of craniofacial morphology in OSA patients
polysomnographyDiagnostic test
to evaluate Apnea-Hypopnea Index (AHI) for the severity of sleep apnea
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At enrollment
Secondary outcomes (8)
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.
Measured: At enrollment
Polysomnography
The evaluation on obstructive sleep apnea severity
Measured: At enrollment
Cephalometry
The evaluation on cranial morphology of enrolled patients
Measured: At enrollment
Lipid profile (mg/dl)
Includes High-density lipoprotein- cholesterol, Low-density lipoprotein- cholesterol, Total cholesterol, Triglyceride.
Measured: At enrollment
Serum leptin test (ng/mL)
High serum leptin level is related to obesity
Measured: At enrollment
Glucose AC (mg/dL)
High glucose AC is related to diabetes.
Measured: At enrollment
HbA1C (Glycohemoglobin, %)
High HbA1C is related to diabetes.
Measured: At enrollment
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start10 Apr 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kun-Hao Jiang, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326244
- Sponsor's protocol ID
- CMRPG1H0052
- Status last verified
- Feb 2020
- First submitted
- 9 Mar 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30600310Shah 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.
PubMed 30828636Jiao 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.
PubMed 31044373Pierola 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.
PubMed 17626108Thorleifsson 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.
PubMed 19079260Yeo 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.
PubMed 28013339Yang 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.
PubMed 28539834
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Obesity-related Molecular Typing and Traditional Chinese Medicine Constitution
- ClinicalTrials.gov ID
- NCT04326244
- Acronym / sponsor ID
- CMRPG1H0052
- Conditions
- Obstructive Sleep Apnea, Obesity
- Keywords
- Obesity, Obstructive Sleep Apnea, Gene, Traditional Chinese medicine constitution
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Snoring obesity patient | – | 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: polysomnographyConstitution 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 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- obesity patient with Obstructive sleep apnea
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood testHigh-density lipoprotein- cholesterol, Low-density lipoprotein- cholesterol, Total cholesterol, Triglyceride, Leptin, Glucose AC, Hemoglobin A1C, Insulin | Diagnostic test | Snoring obesity patient |
| genetic testFTO、MC4R、BDNF、PPARG、ADRB3、UCP1 | Diagnostic test | Snoring obesity patient |
| Constitution in Chinese Medicine QuestionnaireConstitution in Chinese Medicine Questionnaire | Diagnostic test | Snoring obesity patient |
| Epworth Sleepiness ScaleEpworth Sleepiness Scale | Diagnostic test | Snoring obesity patient |
| cephalometryEvaluation of craniofacial morphology in OSA patients | Diagnostic test | Snoring obesity patient |
| polysomnographyto evaluate Apnea-Hypopnea Index (AHI) for the severity of sleep apnea | Diagnostic test | Snoring obesity patient |
Primary outcome
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.
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.
8 secondary outcomes
Epworth Sleepiness Scale
Time frame: At enrollment
Polysomnography
Time frame: At enrollment
Cephalometry
Time frame: At enrollment
Lipid profile (mg/dl)
Time frame: At enrollment
Serum leptin test (ng/mL)
Time frame: At enrollment
Glucose AC (mg/dL)
Time frame: At enrollment
HbA1C (Glycohemoglobin, %)
Time frame: At enrollment
Insulin (uU/mL)
Time frame: At enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Background: PubMed 30600310Bielicki 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.
- Background: PubMed 30828636Shah 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.
- Background: PubMed 31044373Jiao 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.
- Background: PubMed 17626108Pierola 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.
- Background: PubMed 19079260Thorleifsson 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.
- Background: PubMed 28013339Yeo 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.
- Background: PubMed 28539834Yang 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.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kun-Hao Jiang principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Obesity, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Hsuan Lin (+886975366091, cynthiajobo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obesity-related gene profile (time frame: At enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04326244, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020; AzTrials last refreshed its copy on 7 Nov 2026.