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A Traditional Chinese Medicine Cohort Study in Elderly Diabetics with Multiple Metabolic Disorders: the Impact of Suxiao Jiuxin Pill on Major Adverse Cardiovascular Events

A Traditional Chinese Medicine Cohort Study in Elderly Diabetics with Multiple Metabolic Disorders: the Impact of Suxiao Jiuxin Pill on Major Adverse Cardiovascular Events

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026001094
Enrollment
Unknown
Registered
2026-04-28
Start date
2026-04-28
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Elderly Diabetics with Multiple Metabolic Disorders

Interventions

Elderly Diabetics with Multiple Metabolic Disorders Group:Observational cohort study, without intervention measures

Sponsors

Dongfang Hospital Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age =60 and =80 years, regardless of gender; 2) Meet diagnostic criteria for glucose metabolism disorders and multiple metabolic disorders: Any 1 of the following 5 criteria: 1) FPG =6.1 mmol/L; 2) 2-hour postprandial blood glucose =7.8mmol/L; 3) HbA1C =5.7%; 4) Meet Diagnostic Criteria for Elderly Diabetes; 5) Receiving any long-term diabetes treatment. And any 2 of the following 4 criteria: 1) Waist circumference =90 cm (male) or =85 cm (female); 2) Blood pressure =130/80 mmHg or diagnosed hypertension under treatment; 3) TG =1.7 mmol/L or receiving treatment; 4) HDL-C <1.04 mmol/L or receiving treatment. 3) Voluntary participation with signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Special types of diabetes (e.g., pancreatic diabetes, Cushing's syndrome, acromegaly, hyperthyroidism, drug/chemical-induced diabetes, infection-related diabetes); 2) Severe organic heart disease (LVEF<35% or NYHA/Killip class IV); 3) Severe respiratory diseases (acute exacerbation of COPD requiring hospitalization, WHO class III+ pulmonary hypertension, moderate/high-risk pulmonary embolism, oxygenation index <200 mmHg); 4) Child-Pugh Class C liver dysfunction or uncontrolled active viral hepatitis; 5) Chronic renal failure (eGFR <30ml/min/1.73m²) or chronic dialysis; 6) Active malignancy within 5 years (except cured skin basal cell carcinoma/cervical CIS); 7) Major organ transplant recipients; 8) Life expectancy <1 year or uncontrolled active infections; 9) Investigator-determined inability to complete follow-up or comply with study protocols.

Design outcomes

Primary

MeasureTime frame
Major Adverse Cardiovascular Events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke);

Secondary

MeasureTime frame
Components of Primary Observation Indicators;4-point Major Adverse Cardiovascular Events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, emergency revascularization);5-point Major Adverse Cardiovascular Events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, emergency revascularization, hospitalization for heart failure);Worsening angina (Canadian Cardiovascular Society class increases by =1) or hospitalization for unstable angina;New-onset heart failure, worsening heart failure (NYHA class increases by =1), hospitalization for heart failure;Emergency revascularization;Any diabetes-related endpoint (sudden death, hyper/hypoglycemia death, fatal/non-fatal MI, angina, new/worsening heart failure, stroke, renal failure (eGFR decline >50% or ESRD), amputation, vitreous hemorrhage, photocoagulation-requiring retinopathy, monocular blindness, cataract extraction);Microvascular events (first occurrence of renal failure, renal death, blindness, vitreous hemorrhage/retinal photocoagulation, amputation);Newly diagnosed chronic diabetic complications (neuropathy, gastroparesis, enteropathy, neurogenic bladder, ED, retinopathy, nephropathy, cardiomyopathy, foot disease, osteoporosis, infections, dermatopathy);Acute diabetic complications (hypoglycemia, DKA, HHS, lactic acidosis);

Countries

China

Contacts

Public ContactGuo Xiangyu

Dongfang Hospital Beijing University of Chinese Medicine

gxyc1003@163.com17710397258

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026