Metabolic Syndrome XNCT06543706
Metabolic Syndrome and Related Diseases in Healthcare Workers
An observational study of Metabolic Syndrome X and Diabetes Mellitus Type 2, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study aims to investigate the incidence and prevalence of metabolic syndrome and metabolism-related diseases among healthcare workers, identify potential risk factors for these diseases, evaluate the control status of these conditions, and explore the significance of annual regular check-ups in improving… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X, Diabetes Mellitus Type 2, Hypertension
- How many people
- 7,432 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2022to 10 Nov 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthcare workers who were working in the hospital, including those who have retired from the hospital
Who may be able to join
- Age ≥18 years
- Healthcare workers who attend annual check-ups at Peking Union Medical College Hospital
Who cannot join
- Presence of metabolic syndrome, hypertension, diabetes, coronary heart disease, or stroke at the time of the first physical examination between 2012 and 2022
- Malignant neoplasm
- Uremia
- Liver failure
- Moderate to severe heart failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Syndrome and Its Related Diseases in Healthcare Workers: Incidence, Prevalence, and Risk Factors
This study aims to investigate the incidence and prevalence of metabolic syndrome and metabolism-related diseases among healthcare workers, identify potential risk factors for these diseases, evaluate the control status of these conditions, and explore the significance of annual regular check-ups in improving metabolic-related health outcomes. All data for the study subjects are sourced from anonymized continuous records in hospital physical examinations and medical case files. The study does not involve any interventions. Upon obtaining the study data, researchers will use retrospective analysis methods to identify possible associations between risk factors and diseases.
- Conditions
- Metabolic Syndrome X, Diabetes Mellitus Type 2, Hypertension, Hyperlipidemia, Obesity, Cardiovascular Diseases
- Keywords
- metabolic syndrome, metabolic related diseases, medical workers
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Type 2, Hypertension, Hyperlipidemias, Obesity, Cardiovascular Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| the Metabolic Related Diseases in Medical Workers (MRDMW) cohort | The cohort includes all hospital employees who receive annual check-ups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite endpoint of cardiovascular and cerebrovascular diseases
The number of hospitalizations due to severe coronary heart disease, stroke, or sudden cardiac death. The outcome is determined if any of the first three discharge diagnoses include acute myocardial infarction, stroke, or sudden cardiac death, or if an emergency coronary stent placement or coronary artery bypass graft surgery is performed during hospitalization.
Measured: through study completion, an average of 5 years
Secondary outcomes (1)
new-onset metabolic syndrome
The number of individuals who did not meet the criteria for metabolic syndrome at the first examination but developed the syndrome later. The diagnostic criteria for metabolic syndrome involve meeting three or more of the following conditions:
Abdominal obesity: waist circumference ≥90 (men) or ≥85 (women) cm. Hyperglycemia: fasting blood glucose ≥6.1 or 2-hour postprandial blood glucose ≥7.8 mmol/L or previously diagnosed diabetes. Hypertension: blood pressure ≥130/85 mmHg or previously diagnosed hypertension. Elevated triglycerides: fasting triglycerides ≥1.70 mmol/L or on lipid-lowering medication. Low fasting high-density lipoprotein cholesterol (HDL-C) <1.04 mmol/L.
If waist circumference and HDL-C data are missing, abdominal obesity will be defined using the body mass index (BMI), calculated by dividing weight in kilograms by the square of height in meters (BMI ≥ 28.0 kg/m^2). Total cholesterol ≥ 5.17 mmol/L will be used as a substitute for the HDL-C indicator.
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start18 Nov 2022
- Primary completion7 Aug 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tengda Xu, Principal investigator, Department of Health, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543706
- Sponsor's protocol ID
- K2557
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual patient data (IPD) could be shared with other researchers after the publication of the study. However, the sharing should be permitted by the principal investigator from email. We do not have a web address for finding more information about the individual patient data (IPD) sharing plan. And we reject any data requests with commercial intentions.
Publications
Strauss M, Lavie CJ, Lippi G, Brzek A, Vollenberg R, Sanchis-Gomar F, Leischik R. A systematic review of prevalence of metabolic syndrome in occupational groups - Does occupation matter in the global epidemic of metabolic syndrome? Prog Cardiovasc Dis. 2022 Nov-Dec;75:69-77. doi: 10.1016/j.pcad.2022.09.003. Epub 2022 Sep 23.
PubMed 36162483Liu J, Liu Q, Li Z, Du J, Wang C, Gao Y, Wei Z, Wang J, Shi Y, Su J, Liu Y, Wang P, Xie C, Li G, Shao B, Zhang L. Prevalence of Metabolic Syndrome and Risk Factors Among Chinese Adults: Results from a Population-Based Study - Beijing, China, 2017-2018. China CDC Wkly. 2022 Jul 22;4(29):640-645. doi: 10.46234/ccdcw2022.138.
PubMed 35919823Xi B, He D, Hu Y, Zhou D. Prevalence of metabolic syndrome and its influencing factors among the Chinese adults: the China Health and Nutrition Survey in 2009. Prev Med. 2013 Dec;57(6):867-71. doi: 10.1016/j.ypmed.2013.09.023. Epub 2013 Oct 5.
PubMed 24103567
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Syndrome and Its Related Diseases in Healthcare Workers: Incidence, Prevalence, and Risk Factors
- ClinicalTrials.gov ID
- NCT06543706
- Acronym / sponsor ID
- K2557
- Conditions
- Metabolic Syndrome X, Diabetes Mellitus Type 2, Hypertension, Hyperlipidemia, Obesity, Cardiovascular Diseases
- Keywords
- metabolic syndrome, metabolic related diseases, medical workers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,432 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 9 Aug 2024 (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.
This study aims to investigate the incidence and prevalence of metabolic syndrome and metabolism-related diseases among healthcare workers, identify potential risk factors for these diseases, evaluate the control status of these conditions, and explore the significance of annual regular check-ups in improving metabolic-related health outcomes. All data for the study subjects are sourced from anonymized continuous records in hospital physical examinations and medical case files. The study does not involve any interventions. Upon obtaining the study data, researchers will use retrospective analysis methods to identify possible associations between risk factors and diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the Metabolic Related Diseases in Medical Workers (MRDMW) cohort | – | –The cohort includes all hospital employees who receive annual check-ups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare workers who were working in the hospital, including those who have retired from the hospital
Key inclusion criteria (2 listed)
- Age ≥18 years
- Healthcare workers who attend annual check-ups at Peking Union Medical College Hospital
Key exclusion criteria (5 listed)
- Presence of metabolic syndrome, hypertension, diabetes, coronary heart disease, or stroke at the time of the first physical examination between 2012 and 2022
- Malignant neoplasm
- Uremia
- Liver failure
- Moderate to severe heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
composite endpoint of cardiovascular and cerebrovascular diseases
Time frame: through study completion, an average of 5 years
The number of hospitalizations due to severe coronary heart disease, stroke, or sudden cardiac death. The outcome is determined if any of the first three discharge diagnoses include acute myocardial infarction, stroke, or sudden cardiac death, or if an emergency coronary stent placement or coronary artery bypass graft surgery is performed during hospitalization.
1 secondary outcome
new-onset metabolic syndrome
Time frame: through study completion, an average of 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Results publication: PubMed 36162483Strauss M, Lavie CJ, Lippi G, Brzek A, Vollenberg R, Sanchis-Gomar F, Leischik R. A systematic review of prevalence of metabolic syndrome in occupational groups - Does occupation matter in the global epidemic of metabolic syndrome? Prog Cardiovasc Dis. 2022 Nov-Dec;75:69-77. doi: 10.1016/j.pcad.2022.09.003. Epub 2022 Sep 23.
- Results publication: PubMed 35919823Liu J, Liu Q, Li Z, Du J, Wang C, Gao Y, Wei Z, Wang J, Shi Y, Su J, Liu Y, Wang P, Xie C, Li G, Shao B, Zhang L. Prevalence of Metabolic Syndrome and Risk Factors Among Chinese Adults: Results from a Population-Based Study - Beijing, China, 2017-2018. China CDC Wkly. 2022 Jul 22;4(29):640-645. doi: 10.46234/ccdcw2022.138.
- Results publication: PubMed 24103567Xi B, He D, Hu Y, Zhou D. Prevalence of metabolic syndrome and its influencing factors among the Chinese adults: the China Health and Nutrition Survey in 2009. Prev Med. 2013 Dec;57(6):867-71. doi: 10.1016/j.ypmed.2013.09.023. Epub 2013 Oct 5.
- Individual participant dataSharing planned: Undecided. Individual patient data (IPD) could be shared with other researchers after the publication of the study. However, the sharing should be permitted by the principal investigator from email. We do not have a web address for finding more information about the individual patient data (IPD) sharing plan. And we reject any data requests with commercial intentions.
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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.
Tengda Xu principal investigator
Department of Health, Peking Union Medical College 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 Metabolic Syndrome X and Diabetes Mellitus Type 2, run by Peking Union Medical College Hospital at 1 site in China.
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 2 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: finished, as of the sponsor's last update on 9 Aug 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite endpoint of cardiovascular and cerebrovascular diseases (time frame: through study completion, an average of 5 years). 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 NCT06543706, which also lists 3 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 9 Aug 2024.