Metabolic Syndrome and Prediabetes

NCT ID: NCT07243821

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-31

Study Completion Date

2028-09-01

Brief Summary

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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

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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

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Metabolic Syndrome Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Adults aged 18 years or older.
2. Individuals clinically diagnosed by a physician as having metabolic syndrome (meeting at least three of the following five criteria) or prediabetes:

(A) Waist circumference: ≥ 90 cm in men or ≥ 80 cm in women, or body mass index (BMI) ≥ 27 kg/m².

(B) Fasting plasma glucose (AC): ≥ 100 mg/dL. (C) Blood pressure: Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg.

(D) Triglycerides (TG): ≥ 150 mg/dL. (E) High-density lipoprotein cholesterol (HDL-C): \< 40 mg/dL in men or \< 50 mg/dL in women.
3. Individuals meeting the definition of prediabetes, defined as glycated hemoglobin (HbA1c) between 5.7% and 6.4%.
4. Participants who are willing to participate in the study and have signed written informed consent.
5. Participants who are able to complete basic physical examinations and assessment procedures.

Exclusion Criteria

1. Individuals unable to comprehend the study information or procedures.
2. Individuals unable to comply with the required assessments or study protocols.
3. Any other condition that, in the clinical judgment of the principal investigator, deems the individual unsuitable for participation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chia-Wen Lu, Present Professor

Role: STUDY_CHAIR

Department of Family Medicine, National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, Zhongzheng Dist, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chia-Wen Lu, Present Professor

Role: CONTACT

886-2-23123456 ext. 266703

Other Identifiers

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202509097RINB

Identifier Type: -

Identifier Source: org_study_id

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