Metabolic SyndromeNCT07243821
Metabolic Syndrome and Prediabetes
An observational study of Metabolic Syndrome and Diabetes, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims to establish a cohort of individuals with metabolic syndrome and prediabetes to enable long-term follow-up of risk factors, disease progression, and the development of obesity-related complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome, Diabetes
- How many people
- 2,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Oct 2025to 1 Sep 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: articipants eligible for inclusion are adults aged 18 years or older who have been clinically diagnosed with either metabolic syndrome or prediabetes. Metabolic syndrome is defined by the presence of at least three of the following five criteria: (A) waist circumference ≥ 90 cm in men or ≥ 80 cm in women, or a body mass index (BMI) ≥ 27 kg/m²; (B) fasting plasma glucose ≥ 100 mg/dL; (C) systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg; (D) triglycerides ≥ 150 mg/dL; and (E) high-density lipoprotein cholesterol (HDL-C) < 40 mg/dL in men or < 50 mg/dL in women. Participants meeting the definition of prediabetes, defined as glycated hemoglobin (HbA1c) levels between 5.7% and 6.4%, will also be eligible. All participants must be willing to join the study, provide written informed consent, and be able to complete basic physical examinations and assessment procedures.
Who may be able to join
- Adults aged 18 years or older.
- Individuals clinically diagnosed by a physician as having metabolic syndrome (meeting at least three of the following five criteria) or prediabetes:
- Waist circumference: ≥ 90 cm in men or ≥ 80 cm in women, or body mass index (BMI) ≥ 27 kg/m².
- Fasting plasma glucose (AC): ≥ 100 mg/dL. (C) Blood pressure: Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg.
- Triglycerides (TG): ≥ 150 mg/dL. (E) High-density lipoprotein cholesterol (HDL-C): < 40 mg/dL in men or < 50 mg/dL in women.
- Individuals meeting the definition of prediabetes, defined as glycated hemoglobin (HbA1c) between 5.7% and 6.4%.
- Participants who are willing to participate in the study and have signed written informed consent.
- Participants who are able to complete basic physical examinations and assessment procedures.
Who cannot join
- Individuals unable to comprehend the study information or procedures.
- Individuals unable to comply with the required assessments or study protocols.
- Any other condition that, in the clinical judgment of the principal investigator, deems the individual unsuitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Zhongzheng Dist, 100229
About this study
Official title: Cohort Studies on Metabolic Syndrome and Prediabetes
This study aims to establish a cohort of individuals with metabolic syndrome and prediabetes to enable long-term follow-up of risk factors, disease progression, and the development of obesity-related complications. The study will also monitor changes in nutritional status and physical function over time, in order to identify key prognostic determinants influencing clinical outcomes.
Metabolic syndrome and prediabetes are chronic multisystem disorders, and poor long-term control is closely associated with the development of various complications. Moreover, malnutrition and functional decline are common comorbid conditions that further impair quality of life and impose a substantial burden on healthcare resources.
Read the detailed description
Metabolic syndrome has been recognized as a significant contributor to the development of major chronic diseases, including cerebrovascular disorders, cardiovascular disease, diabetes mellitus, and hypertension. Compared with the general population, individuals with metabolic syndrome exhibit an approximately sixfold increased risk of diabetes, fourfold risk of hypertension, threefold risk of dyslipidemia, and twofold risk of stroke and coronary heart disease.
The condition is strongly influenced by dietary and lifestyle factors. Its core pathophysiological features are insulin resistance and central obesity, and there is a high degree of comorbidity between metabolic syndrome and prediabetes.
The establishment of a comprehensive cohort and database for individuals with metabolic syndrome and prediabetes will facilitate the systematic collection of metabolic profiles and disease-related biomarkers. This will enable longitudinal analyses of systemic and organ-specific complications, their incidence, and predictive determinants, thereby strengthening disease risk stratification and early identification.
This study aims to collect routine clinical, physiological, and nutritional data at regular intervals to examine associations among lifestyle behaviors, metabolic factors, physiological indicators, and the development of complications. Furthermore, it seeks to evaluate nutritional and functional status, identify potential prognostic biomarkers, and provide a foundation for individualized therapeutic approaches and integrated healthcare models.
- Conditions
- Metabolic Syndrome, Diabetes
- Keywords
- Obesity, Nutrition, Physical activity, Diabetes, Body composition, Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Obesity, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical record system and on-site inspection data collection
Measured: Everytime after physician's appointment(Usually 3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start31 Oct 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (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 National Taiwan University 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Wen Lu, Present Professor, Study chair, Department of Family Medicine, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243821
- Sponsor's protocol ID
- 202509097RINB
- Status last verified
- Oct 2025
- First submitted
- 17 Nov 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Studies on Metabolic Syndrome and Prediabetes
- ClinicalTrials.gov ID
- NCT07243821
- Acronym / sponsor ID
- 202509097RINB
- Conditions
- Metabolic Syndrome, Diabetes
- Keywords
- Obesity, Nutrition, Physical activity, Diabetes, Body composition, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 24 Nov 2025 (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 establish a cohort of individuals with metabolic syndrome and prediabetes to enable long-term follow-up of risk factors, disease progression, and the development of obesity-related complications. The study will also monitor changes in nutritional status and physical function over time, in order to identify key prognostic determinants influencing clinical outcomes.
Metabolic syndrome and prediabetes are chronic multisystem disorders, and poor long-term control is closely associated with the development of various complications. Moreover, malnutrition and functional decline are common comorbid conditions that further impair quality of life and impose a substantial burden on healthcare resources.
Detailed description
Metabolic syndrome has been recognized as a significant contributor to the development of major chronic diseases, including cerebrovascular disorders, cardiovascular disease, diabetes mellitus, and hypertension. Compared with the general population, individuals with metabolic syndrome exhibit an approximately sixfold increased risk of diabetes, fourfold risk of hypertension, threefold risk of dyslipidemia, and twofold risk of stroke and coronary heart disease.
The condition is strongly influenced by dietary and lifestyle factors. Its core pathophysiological features are insulin resistance and central obesity, and there is a high degree of comorbidity between metabolic syndrome and prediabetes.
The establishment of a comprehensive cohort and database for individuals with metabolic syndrome and prediabetes will facilitate the systematic collection of metabolic profiles and disease-related biomarkers. This will enable longitudinal analyses of systemic and organ-specific complications, their incidence, and predictive determinants, thereby strengthening disease risk stratification and early identification.
This study aims to collect routine clinical, physiological, and nutritional data at regular intervals to examine associations among lifestyle behaviors, metabolic factors, physiological indicators, and the development of complications. Furthermore, it seeks to evaluate nutritional and functional status, identify potential prognostic biomarkers, and provide a foundation for individualized therapeutic approaches and integrated healthcare models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- articipants eligible for inclusion are adults aged 18 years or older who have been clinically diagnosed with either metabolic syndrome or prediabetes. Metabolic syndrome is defined by the presence of at least three of the following five criteria: (A) waist circumference ≥ 90 cm in men or ≥ 80 cm in women, or a body mass index (BMI) ≥ 27 kg/m²; (B) fasting plasma glucose ≥ 100 mg/dL; (C) systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg; (D) triglycerides ≥ 150 mg/dL; and (E) high-density lipoprotein cholesterol (HDL-C) < 40 mg/dL in men or < 50 mg/dL in women. Participants meeting the definition of prediabetes, defined as glycated hemoglobin (HbA1c) levels between 5.7% and 6.4%, will also be eligible. All participants must be willing to join the study, provide written informed consent, and be able to complete basic physical examinations and assessment procedures.
Key inclusion criteria (8 listed)
- Adults aged 18 years or older.
- Individuals clinically diagnosed by a physician as having metabolic syndrome (meeting at least three of the following five criteria) or prediabetes:
- Individuals meeting the definition of prediabetes, defined as glycated hemoglobin (HbA1c) between 5.7% and 6.4%.
- Participants who are willing to participate in the study and have signed written informed consent.
- Participants who are able to complete basic physical examinations and assessment procedures.
Key exclusion criteria (3 listed)
- Individuals unable to comprehend the study information or procedures.
- Individuals unable to comply with the required assessments or study protocols.
- Any other condition that, in the clinical judgment of the principal investigator, deems the individual unsuitable for participation.
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
Medical record system and on-site inspection data collection
Time frame: Everytime after physician's appointment(Usually 3 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Chia-Wen Lu, Present Professor study chair
Department of Family Medicine, National Taiwan University 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 and Diabetes, run by National Taiwan University 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 8 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chia-Wen Lu, Present Professor (886-2-23123456 ext. 266703, biopsycosocial@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical record system and on-site inspection data collection (time frame: Everytime after physician's appointment(Usually 3 months).). 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 17 Sep 2026.