An Epidemiological and Long-Term Endpoint Registry Study on Disease-Syndrome Correlation Patterns in Comorbid Population With Diabetes and Ischemic Cardio-Cerebrovascular Disease

N/ANot Yet RecruitingNCT07104422

Guangzhou University of Traditional Chinese Medicine12,000 enrolled

Overview

Explore the characteristics of TCM syndrome elements and distribution patterns of syndrome types in comorbid populations; Screen for "high-risk syndrome patterns" and frequently co-occurring complex syndromes; Identify characteristic syndrome patterns at key stages: acute phase, recovery phase, and upon occurrence of endpoint events; Investigate the temporal evolution of TCM syndrome patterns and the disease-syndrome correlation patterns in comorbid patients.

A registry study of 12,000 real-world patients with comorbidities is conducted to collect and investigate the epidemiological characteristics of populations with "Tang-Nao" (diabetes with cerebrovascular disease), "Tang-Xin" (diabetes with cardiovascular disease), and triple comorbidities. Through syndrome epidemiology surveys, multi-timepoint cross-sectional investigations on the TCM syndrome of "Toxin Damaging Collaterals" are performed to explore the characteristics of TCM syndrome elements and distribution patterns of syndrome types in comorbid populations, screen "high-risk syndromes" and frequently co-occurring complex syndromes, identify characteristic syndromes at acute phase, recovery phase, and upon occurrence of endpoint events, and investigate the evolution of TCM syndromes and disease-syndrome correlation patterns in comorbid patients.

Study Type

OBSERVATIONAL

Enrollment

12,000

Conditions

Type 2 Diabetes Mellitus (T2DM)Cardiovascular Complications

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged ≥ 18 years Diagnosed with comorbidities relevant to "toxin-damaged collaterals" theory (e.g., type 2 diabetes mellitus with cardiovascular/cerebrovascular disease). Voluntary participation with signed informed consent. Exclusion Criteria: * Acute infectious diseases, malignant tumors, or autoimmune disorders. Mental illness or cognitive impairment affecting symptom assessment.

Outcomes

Primary Outcomes

Pattern (or Syndrome) Evolution Law in Traditional Chinese Medicine (TCM)

Based on the TCM theory of "toxin-damaged collaterals," this outcome measures the dynamic changes in syndrome patterns (including qi deficiency, phlegm-dampness, heat-toxin, etc.) and their transition rules in patients with comorbidities. Assessment will use a standardized "Toxin-Damaged Collaterals Syndrome Collection Form", integrating four diagnostic methods (tongue coating, pulse, symptom scores, and syndrome differentiation results) at multiple follow-up time points to quantify syndrome evolution trends.

Time frame: Baseline (enrollment, T0) and follow-up at 3 months (T1), 6 months (T2) with data collected through clinical visits and standardized syndrome assessment forms.