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

NCT ID: NCT07104422

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 12000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2028-07-30

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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Cardiovascular Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

T2DM-CVD, T2DM-CeVD，T2DM-CVD&CeVD

T2DM-CVD: Type 2 diabetes with ischemic cardiovascular disease (coronary artery disease/heart failure), excluding cerebrovascular involvement.

2. T2DM-CeVD: Type 2 diabetes with ischemic cerebrovascular disease (ischemic stroke/TIA), excluding cardiovascular involvement.

3. T2DM-CVD&CeVD: Type 2 diabetes comorbid with both ischemic cardiovascular and cerebrovascular diseases.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

An Epidemiological and Long-Te

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023ZD0505601

Identifier Type: -

Identifier Source: org_study_id