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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07104422

Acronym

Diabetes

Enrollment

12000

Registered

2025-08-05

Start date

2025-08-15

Completion date

2028-07-30

Last updated

2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Complications, Type 2 Diabetes Mellitus (T2DM)

Keywords

Diabetes comorbidities, Cardiovascular-cerebrovascular diseases, Real-world registry study, Disease-syndrome correlation

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Pattern (or Syndrome) Evolution Law in Traditional Chinese Medicine (TCM)	Baseline (enrollment, T0) and follow-up at 3 months (T1), 6 months (T2) with data collected through clinical visits and standardized syndrome assessment forms.	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.

Outcome results