NCT07243821

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Oct 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Oct 2025Sep 2028

Study Start

First participant enrolled

October 31, 2025

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

November 24, 2025

Status Verified

October 1, 2025

Enrollment Period

2.8 years

First QC Date

November 17, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

ObesityNutritionPhysical activityDiabetesBody compositionMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Medical record system and on-site inspection data collection

    Everytime after physician's appointment(Usually 3 months).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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:
  • (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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng Dist, 100229, Taiwan

RECRUITING

MeSH Terms

Conditions

Metabolic SyndromeDiabetes MellitusObesityMotor Activity

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Chia-Wen Lu, Present Professor

    Department of Family Medicine, National Taiwan University Hospital

    STUDY CHAIR

Central Study Contacts

Chia-Wen Lu, Present Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 24, 2025

Study Start

October 31, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

November 24, 2025

Record last verified: 2025-10

Locations