Metabolic SyndromeNCT03489317
Gut Microbiomes in Patients With Metabolic Syndrome
An observational study of Metabolic Syndrome, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
Metabolic syndrome (MS) is defined by a manifestation of cardiometabolic risk factors including high blood pressure, glucose and triglycerides, low high-density lipoprotein (HDL) cholesterol, and abdominal obesity. It is closely associated with other diseases such as fatty liver and gouty arthritis. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Metformin, lifestyle modification and Simvastatin 10mg
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 2 sitesHong Kong
- Study dates
- 27 Nov 2017to Dec 2021
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of Hong Kong will be invited from health talks, blogs, notices and advertisement through various public media channels, as well as patients referred to the Lek Yuen Health Centre, a university teaching clinic, for suspected or confirmed metabolic syndrome.
Who may be able to join
- Resident of Hong Kong
Who cannot join
- Major organ system impairment such as heart failure, renal failure, and severe impairment of respiratory function.
- On long-term regular immunosuppressive therapy
- Current or history of malignancy
- Current or history of major gastrointestinal diseases, including inflammatory bowel disease, major gastrointestinal surgery
- On medication for glucose or lipid control, such as metformin and statin
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites, 2 recruiting
- Recruiting
Department of Microbiology, Chinese University of Hong Kong
Shatin
Yun Kit Yeoh, 85235053333, yeohyunkit@cuhk.edu.hk
- Recruiting
Lek Yuen Health Centre
Shatin
Martin Wong, 85222528782, wong_martin@cuhk.edu.hk
About this study
Official title: Gut Microbiomes and Viromes in Patients With Metabolic Syndrome
Metabolic syndrome (MS) is defined by a manifestation of cardiometabolic risk factors including high blood pressure, glucose and triglycerides, low high-density lipoprotein (HDL) cholesterol, and abdominal obesity. It is closely associated with other diseases such as fatty liver and gouty arthritis. In recent years there is evidence that gut microorganisms are intimately linked to health and wellbeing. Here, the investigators hypothesize that gut microorganisms are involved in the regulation and/or onset of MS and its symptoms.
Read the detailed description
There is mounting evidence that the gut microbiome plays a vital role in health and wellbeing. In particular, population-association and mouse model studies have demonstrated that gut bacteria can be reproducibly linked to obesity and diabetes. There is, however, a lack of progress in translating current scientific knowledge to healthcare practices in part due to the strong influence of biogeography and demography on gut microbiomes. Another major knowledge gap in gut microbiomes is the ecology of gut viruses and their associations with MS despite having intimate relationships with human and bacterial hosts.
In this study, the investigators aim to assess variation in the gut microbiomes of patients with MS with reference to the healthy population in Hong Kong, and to explore gut microorganisms as predictive/diagnostic markers of MS and clinical outcomes associated with medical interventions. This will be achieved through studying microorganisms in the stools of participants. The investigators will use the 16S small subunit ribosomal RNA (16S rRNA) marker gene to create compositional profiles of the gut microbial community in healthy and individuals with MS to identify bacterial populations that are associated with the onset and progression of MS. A subset of samples will be selected for bulk DNA sequencing based on their stool community profiles and/or MS parameters to obtain genomic information of the microorganisms involved.
Participants who undergo intervention as part of their routine medical care for MS will be invited to provide stool samples following intervention. These stools will be used to profile gut microbial communities to investigate whether their compositions undergo changes reflective of medical intervention. Here, the aim is to investigate whether resolution of MS symptoms can be linked to alterations in gut microorganisms, and the hypothesis is that their profiles will more closely resemble healthy individuals following medical intervention.
- Conditions
- Metabolic Syndrome
- Being tested
- Metformin, lifestyle modification, Simvastatin 10mg, Amlodipine 5mg
- Keywords
- gut microbiome, stool
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Participants with high glucose levels will usually be prescribed Metformin 250 mg three times daily. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.
lifestyle modificationBehavioural
Participants with metabolic syndrome will be offered advice on modifying their diets and exercise regimes. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.
Simvastatin 10mgDrug
Participants with elevated lipid levels will usually be prescribed simvastatin 10 mg at night. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.
Amlodipine 5mgDrug
Participants with high blood pressure could be prescribed antihypertensive medicine such as Amlodipine. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.
| Study group | Role | What they receive |
|---|---|---|
| No metabolic syndrome | Participants who do not fulfill any of the five criteria for metabolic syndrome defined by the International Diabetes Federation. | |
| Metabolic syndrome- partial | Participants who fulfill one or two of the five criteria for metabolic syndrome defined by the International Diabetes Federation. Receives: Drug: Metformin; Behavioral: lifestyle modification; Drug: Simvastatin 10mg; Drug: Amlodipine 5mg | |
| Metabolic syndrome- full | Participants who fulfill three or more of the five criteria for metabolic syndrome defined by the International Diabetes Federation. Receives: Drug: Metformin; Behavioral: lifestyle modification; Drug: Simvastatin 10mg; Drug: Amlodipine 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in waist circumference at four weeks
Waist circumference is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a circumference of ≥90 cm (male) or ≥80 cm (female) is a criteria for metabolic syndrome. The investigators will measure this in participants receiving drug-based treatment before and four weeks after medical intervention, and assess stool microbial community compositions to determine whether any changes in waist circumference can be associated with gut microorganisms.
Measured: four weeks in participants receiving drug intervention for metabolic syndrome
Change in baseline systolic and diastolic blood pressure at four weeks
Blood pressure is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a blood pressure reading of ≥130/85 mm Hg (systolic/diastolic pressure) is a criteria for metabolic syndrome. The investigators will measure this in participants receiving drug-based treatment before and four weeks after medical intervention, and assess stool microbial community compositions to determine whether any changes in baseline systolic and diastolic blood pressure can be associated with gut microorganisms.
Measured: four weeks in participants receiving drug intervention for metabolic syndrome
Change in blood triglyceride levels at four weeks
Blood triglyceride concentration is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a triglyceride level of ≥1.7 mmol/L is a criteria for metabolic syndrome. The investigators will measure this in participants receiving drug-based treatment before and four weeks after medical intervention, and assess stool microbial community compositions to determine whether any changes in blood triglyceride levels can be associated with gut microorganisms.
Measured: four weeks in participants receiving drug intervention for metabolic syndrome
Change in high-density lipoprotein (HDL) cholesterol levels at four weeks
High-density lipoprotein (HDL) cholesterol levels is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a HDL cholesterol level of <1.03 mmol/L (males) or <1.29 mmol/L (females) is a criteria for metabolic syndrome. The investigators will measure this in participants receiving drug-based treatment before and four weeks after medical intervention, and assess stool microbial community compositions to determine whether HDL cholesterol levels can be associated with gut microorganisms.
Measured: four weeks in participants receiving drug intervention for metabolic syndrome
Change in fasting blood sugar levels at four weeks
Fasting blood sugar levels is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a fasting blood sugar level of ≥5.6 mmol/L is a criteria for metabolic syndrome. The investigators will measure this in participants receiving drug-based treatment before and four weeks after medical intervention, and assess stool microbial community compositions to determine whether fasting blood sugar levels can be associated with gut microorganisms.
Measured: four weeks in participants receiving drug intervention for metabolic syndrome
Change in waist circumference at six months
Waist circumference is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a circumference of ≥90 cm (male) or ≥80 cm (female) is a criteria for metabolic syndrome. The investigators will measure this in all participants with metabolic syndrome six months after their initial visit, and assess stool microbial community compositions to determine whether any changes in waist circumference can be associated with gut microorganisms.
Measured: six months in all participants with metabolic syndrome
Change in baseline systolic and diastolic blood pressure at six months
Blood pressure is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a blood pressure reading of ≥130/85 mm Hg (systolic/diastolic pressure) is a criteria for metabolic syndrome. The investigators will measure this in all participants with metabolic syndrome six months after their initial visit, and assess stool microbial community compositions to determine whether any changes in baseline systolic and diastolic blood pressure can be associated with gut microorganisms.
Measured: six months in all participants with metabolic syndrome
Change in blood triglyceride levels at six months
Blood triglyceride concentration is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a triglyceride level of ≥1.7 mmol/L is a criteria for metabolic syndrome. The investigators will measure this in all participants with metabolic syndrome six months after their initial visit, and assess stool microbial community compositions to determine whether any changes in blood triglyceride levels can be associated with gut microorganisms.
Measured: six months in all participants with metabolic syndrome
Change in high-density lipoprotein (HDL) cholesterol levels at six months
High-density lipoprotein (HDL) cholesterol levels is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a HDL cholesterol level of <1.03 mmol/L (males) or <1.29 mmol/L (females) is a criteria for metabolic syndrome. The investigators will measure this in all participants with metabolic syndrome six months after their initial visit, and assess stool microbial community compositions to determine whether HDL cholesterol levels can be associated with gut microorganisms.
Measured: six months in all participants with metabolic syndrome
Change in fasting blood sugar levels at six months
Fasting blood sugar levels is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a fasting blood sugar level of ≥5.6 mmol/L is a criteria for metabolic syndrome. The investigators will measure this in all participants with metabolic syndrome six months after their initial visit, and assess stool microbial community compositions to determine whether fasting blood sugar levels can be associated with gut microorganisms.
Measured: six months in all participants with metabolic syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start27 Nov 2017
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeoh Yun Kit, Chinese University of Hong Kong
- Investigators
- Yun Kit Yeoh, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489317
- Sponsor's protocol ID
- 2017.514
- Status last verified
- Jul 2018
- First submitted
- 23 Mar 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Participant data may be shared with researchers within the Faculty of Medicine at the Chinese University of Hong Kong, however, these will likely be limited to the healthy cohort as controls for other gut community surveys or the metabolic syndrome cohort for research into closely related medical conditions such as hypertension. The investigators will share participant clinical (blood pressure, waist circumference, fasting blood sugar, triglycerides), demography (age, gender, medical history, etc) and gut microbial community composition data within the department where the need arises and appropriate approvals have been obtained.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiomes and Viromes in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03489317
- Acronym / sponsor ID
- 2017.514
- Conditions
- Metabolic Syndrome
- Keywords
- gut microbiome, stool
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Apr 2018 (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.
Metabolic syndrome (MS) is defined by a manifestation of cardiometabolic risk factors including high blood pressure, glucose and triglycerides, low high-density lipoprotein (HDL) cholesterol, and abdominal obesity. It is closely associated with other diseases such as fatty liver and gouty arthritis. In recent years there is evidence that gut microorganisms are intimately linked to health and wellbeing. Here, the investigators hypothesize that gut microorganisms are involved in the regulation and/or onset of MS and its symptoms.
Detailed description
There is mounting evidence that the gut microbiome plays a vital role in health and wellbeing. In particular, population-association and mouse model studies have demonstrated that gut bacteria can be reproducibly linked to obesity and diabetes. There is, however, a lack of progress in translating current scientific knowledge to healthcare practices in part due to the strong influence of biogeography and demography on gut microbiomes. Another major knowledge gap in gut microbiomes is the ecology of gut viruses and their associations with MS despite having intimate relationships with human and bacterial hosts.
In this study, the investigators aim to assess variation in the gut microbiomes of patients with MS with reference to the healthy population in Hong Kong, and to explore gut microorganisms as predictive/diagnostic markers of MS and clinical outcomes associated with medical interventions. This will be achieved through studying microorganisms in the stools of participants. The investigators will use the 16S small subunit ribosomal RNA (16S rRNA) marker gene to create compositional profiles of the gut microbial community in healthy and individuals with MS to identify bacterial populations that are associated with the onset and progression of MS. A subset of samples will be selected for bulk DNA sequencing based on their stool community profiles and/or MS parameters to obtain genomic information of the microorganisms involved.
Participants who undergo intervention as part of their routine medical care for MS will be invited to provide stool samples following intervention. These stools will be used to profile gut microbial communities to investigate whether their compositions undergo changes reflective of medical intervention. Here, the aim is to investigate whether resolution of MS symptoms can be linked to alterations in gut microorganisms, and the hypothesis is that their profiles will more closely resemble healthy individuals following medical intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No metabolic syndrome | – | –Participants who do not fulfill any of the five criteria for metabolic syndrome defined by the International Diabetes Federation. |
| Metabolic syndrome- partial | – | Drug: Metformin, Behavioral: lifestyle modification, Drug: Simvastatin 10mg, Drug: Amlodipine 5mgParticipants who fulfill one or two of the five criteria for metabolic syndrome defined by the International Diabetes Federation. |
| Metabolic syndrome- full | – | Drug: Metformin, Behavioral: lifestyle modification, Drug: Simvastatin 10mg, Drug: Amlodipine 5mgParticipants who fulfill three or more of the five criteria for metabolic syndrome defined by the International Diabetes Federation. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of Hong Kong will be invited from health talks, blogs, notices and advertisement through various public media channels, as well as patients referred to the Lek Yuen Health Centre, a university teaching clinic, for suspected or confirmed metabolic syndrome.
Key inclusion criteria (1 listed)
- Resident of Hong Kong
Key exclusion criteria (5 listed)
- Major organ system impairment such as heart failure, renal failure, and severe impairment of respiratory function.
- On long-term regular immunosuppressive therapy
- Current or history of malignancy
- Current or history of major gastrointestinal diseases, including inflammatory bowel disease, major gastrointestinal surgery
- On medication for glucose or lipid control, such as metformin and statin
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 |
|---|---|---|
| MetforminParticipants with high glucose levels will usually be prescribed Metformin 250 mg three times daily. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions. | Drug | Metabolic syndrome- full, Metabolic syndrome- partial |
| lifestyle modificationParticipants with metabolic syndrome will be offered advice on modifying their diets and exercise regimes. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions. | Behavioural | Metabolic syndrome- full, Metabolic syndrome- partial |
| Simvastatin 10mgParticipants with elevated lipid levels will usually be prescribed simvastatin 10 mg at night. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions. | Drug | Metabolic syndrome- full, Metabolic syndrome- partial |
| Amlodipine 5mgParticipants with high blood pressure could be prescribed antihypertensive medicine such as Amlodipine. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions. | Drug | Metabolic syndrome- full, Metabolic syndrome- partial |
Primary outcome
Change in waist circumference at four weeks
Time frame: four weeks in participants receiving drug intervention for metabolic syndrome
Waist circumference is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a circumference of ≥90 cm (male) or ≥80 cm (female) is a criteria for metabolic syndrome. The investigators will measure this in participants receiving drug-based treatment before and four weeks after medical intervention, and assess stool microbial community compositions to determine whether any changes in waist circumference can be associated with gut microorganisms.
Change in baseline systolic and diastolic blood pressure at four weeks
Time frame: four weeks in participants receiving drug intervention for metabolic syndrome
Blood pressure is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a blood pressure reading of ≥130/85 mm Hg (systolic/diastolic pressure) is a criteria for metabolic syndrome. The investigators will measure this in participants receiving drug-based treatment before and four weeks after medical intervention, and assess stool microbial community compositions to determine whether any changes in baseline systolic and diastolic blood pressure can be associated with gut microorganisms.
Change in blood triglyceride levels at four weeks
Time frame: four weeks in participants receiving drug intervention for metabolic syndrome
Blood triglyceride concentration is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a triglyceride level of ≥1.7 mmol/L is a criteria for metabolic syndrome. The investigators will measure this in participants receiving drug-based treatment before and four weeks after medical intervention, and assess stool microbial community compositions to determine whether any changes in blood triglyceride levels can be associated with gut microorganisms.
Change in high-density lipoprotein (HDL) cholesterol levels at four weeks
Time frame: four weeks in participants receiving drug intervention for metabolic syndrome
High-density lipoprotein (HDL) cholesterol levels is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a HDL cholesterol level of <1.03 mmol/L (males) or <1.29 mmol/L (females) is a criteria for metabolic syndrome. The investigators will measure this in participants receiving drug-based treatment before and four weeks after medical intervention, and assess stool microbial community compositions to determine whether HDL cholesterol levels can be associated with gut microorganisms.
Change in fasting blood sugar levels at four weeks
Time frame: four weeks in participants receiving drug intervention for metabolic syndrome
Fasting blood sugar levels is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a fasting blood sugar level of ≥5.6 mmol/L is a criteria for metabolic syndrome. The investigators will measure this in participants receiving drug-based treatment before and four weeks after medical intervention, and assess stool microbial community compositions to determine whether fasting blood sugar levels can be associated with gut microorganisms.
Change in waist circumference at six months
Time frame: six months in all participants with metabolic syndrome
Waist circumference is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a circumference of ≥90 cm (male) or ≥80 cm (female) is a criteria for metabolic syndrome. The investigators will measure this in all participants with metabolic syndrome six months after their initial visit, and assess stool microbial community compositions to determine whether any changes in waist circumference can be associated with gut microorganisms.
Change in baseline systolic and diastolic blood pressure at six months
Time frame: six months in all participants with metabolic syndrome
Blood pressure is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a blood pressure reading of ≥130/85 mm Hg (systolic/diastolic pressure) is a criteria for metabolic syndrome. The investigators will measure this in all participants with metabolic syndrome six months after their initial visit, and assess stool microbial community compositions to determine whether any changes in baseline systolic and diastolic blood pressure can be associated with gut microorganisms.
Change in blood triglyceride levels at six months
Time frame: six months in all participants with metabolic syndrome
Blood triglyceride concentration is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a triglyceride level of ≥1.7 mmol/L is a criteria for metabolic syndrome. The investigators will measure this in all participants with metabolic syndrome six months after their initial visit, and assess stool microbial community compositions to determine whether any changes in blood triglyceride levels can be associated with gut microorganisms.
Change in high-density lipoprotein (HDL) cholesterol levels at six months
Time frame: six months in all participants with metabolic syndrome
High-density lipoprotein (HDL) cholesterol levels is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a HDL cholesterol level of <1.03 mmol/L (males) or <1.29 mmol/L (females) is a criteria for metabolic syndrome. The investigators will measure this in all participants with metabolic syndrome six months after their initial visit, and assess stool microbial community compositions to determine whether HDL cholesterol levels can be associated with gut microorganisms.
Change in fasting blood sugar levels at six months
Time frame: six months in all participants with metabolic syndrome
Fasting blood sugar levels is one of the five criteria for classifying metabolic syndrome as defined by the International Diabetes Federation. Specifically, a fasting blood sugar level of ≥5.6 mmol/L is a criteria for metabolic syndrome. The investigators will measure this in all participants with metabolic syndrome six months after their initial visit, and assess stool microbial community compositions to determine whether fasting blood sugar levels can be associated with gut microorganisms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Individual participant dataSharing planned: Undecided. Participant data may be shared with researchers within the Faculty of Medicine at the Chinese University of Hong Kong, however, these will likely be limited to the healthy cohort as controls for other gut community surveys or the metabolic syndrome cohort for research into closely related medical conditions such as hypertension. The investigators will share participant clinical (blood pressure, waist circumference, fasting blood sugar, triglycerides), demography (age, gender, medical history, etc) and gut microbial community composition data within the department where the need arises and appropriate approvals have been obtained.
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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.
Yun Kit Yeoh principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
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 1 inclusion and 5 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 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. 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 Yun Kit Yeoh (85235053333, yeohyunkit@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in waist circumference at four weeks (time frame: four weeks in participants receiving drug intervention for metabolic syndrome). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2018.