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

NCT07104422 | Not Yet Recruiting

• 2 other identifiers: 2023ZD0505601An Epidemiological and Long-Te
• Study Type: observational
• Target: 12,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Cardiovascular Complications

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with comorbid chronic diseases (e.g., diabetes, coronary heart disease) who meet TCM "toxin-damaged collaterals" syndrome criteria.

You may qualify if:

• 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.

You may not qualify if:

• Acute infectious diseases, malignant tumors, or autoimmune disorders. Mental illness or cognitive impairment affecting symptom assessment.

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood Whole blood Stool Lingual coating

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: August 5, 2025

Record last verified: 2025-07