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Not yet recruiting NCT07104422

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

Observational Type 2 Diabetes Mellitus (T2DM) Cardiovascular Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Type 2 Diabetes Mellitus (T2DM), Cardiovascular Complications. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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.

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.

Primary outcome measures

  • 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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07104422 · 2023ZD0505601 · An Epidemiological and Long-Te

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗