What question did this study set out to answer?

The study aims to characterize TCM syndrome profiles in adults with type 2 diabetes and metabolic syndrome.

January 25, 2026JMIR Research Protocols1 citationsOpen Access

Traditional Chinese Medicine Syndrome Differentiation of Adult Patients With Type 2 Diabetes and Metabolic Syndrome: Protocol for a Cross-Sectional Study

JZJialing ZhangHong Kong Baptist University HWHoi Ki WongHong Kong Baptist University ZLZhilin Lin

Key Points

The study aims to characterize TCM syndrome profiles in adults with type 2 diabetes and metabolic syndrome.
Enroll 470 participants diagnosed with T2DM and MetS.
Conduct comprehensive assessments including biochemical profiling and lifestyle evaluations.
Employ latent class analysis to identify TCM syndrome patterns.
Use factor analysis for identifying core syndrome factors.
Perform logistic regression to examine associations between syndromes and metabolic parameters.
Participant recruitment began in November 2024 with over 450 enrolled by October 2025.
Data collection is ongoing with recruitment concluding at the end of December 2025.
The study is expected to provide insights for integrating TCM into chronic disease management.

Abstract

Background The global burden of type 2 diabetes mellitus (T2DM) and metabolic syndrome (MetS) continues to rise, with these conditions significantly increasing risks of cardiovascular disease, disability, and mortality. Traditional Chinese Medicine (TCM) syndrome differentiation, a cornerstone of TCM practice, guides diagnosis and treatment by identifying patterns of disharmony. However, large-scale studies investigating TCM syndrome patterns in T2DM comorbid with MetS remain scarce. Objective This cross-sectional study aims to characterize TCM syndrome profiles in a population diagnosed with T2DM and MetS and evaluate their diagnostic relevance. Methods This cross-sectional study will enroll a cohort of 470 participants diagnosed with T2DM and MetS. All participants will undergo comprehensive assessments, including the Syndrome Differentiation Questionnaire for T2DM and MetS, demographic and anthropometric measurements, biochemical profiling (eg, fasting glucose, glycosylated hemoglobin, and lipid panel), dietary measurement (Food Frequency Questionnaire), physical activity measurement (International Physical Activity Questionnaire Short Form), sleep quality evaluation (Pittsburgh Sleep Quality Index), quality-of-life assessment (Audit of Diabetes-Dependent Quality of Life), stroke risk estimation (Framingham Stroke Risk Score), and retinal imaging. Latent class analysis will be used to identify the TCM syndrome patterns. Factor analysis will be employed to identify core TCM syndrome factors. Hierarchical cluster analysis will be performed to classify TCM syndrome elements, and logistic regression will examine associations between syndrome differentiation, metabolic parameters, lifestyle factors, and disease progression. Results This trial was registered on November 17, 2024. Participant recruitment for this study was initiated in November 2024. As of October 2025, more than 450 eligible participants have been enrolled and have completed data collection. Recruitment is scheduled to conclude on December 31, 2025. Conclusions As the first large-scale clinical study to systematically characterize TCM syndrome differentiation in T2DM-MetS comorbidity, this research will establish syndrome profiles associated with metabolic parameters, lifestyle factors, and disease progression. The findings are expected to provide a framework for integrating TCM syndrome differentiation into chronic disease management, ultimately contributing to personalized treatment strategies and improved patient outcomes in integrative medicine. Trial Registration ClinicalTrials.gov NCT06703684; https://clinicaltrials.gov/study/NCT06703684 International Registered Report Identifier (IRRID) DERR1-10.2196/86217

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