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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Cardiovascular Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

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.

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.

Sponsors and collaborators

Lead sponsor

Guangzhou University of Traditional Chinese Medicine

Other

Registry information

Acronym: Diabetes

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Aug 5, 2025
Registry last updated: Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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