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Diabetes Complications and the Risk of Cardiovascular and Cerebrovascular Diseases

Study of Diabetes Mellitus and Its Complications and the Risk of Cardiovascular and Cerebrovascular Diseases

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04983277
Enrollment
3000
Registered
2021-07-30
Start date
2021-07-31
Completion date
2030-12-31
Last updated
2021-07-30

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

Conditions

Cardiovascular Diseases, Cerebrovascular Disease, Diabetes Complications

Brief summary

This study is intended to include 3000 diabetic patients in our hospital to collect complete medical history data, comprehensively improve the screening of diabetic complications and cardiovascular and cerebrovascular risk assessment.

Detailed description

With the economic development and lifestyle change, the incidence and prevalence of diabetes are increasing year by year in both China and the world. Diabetics are associated with a significantly increased risk of cardiovascular and cerebrovascular disease. It is a cross-sectional study. This study intended to include about 3000 adult patients with previously diagnosed diabetes mellitus, then collect their anthropometric data (age, gender, weight, height, waist circumference, hip circumference and etc.), life history (diet, exercise, smoking, drinking and etc.), medical history, familial medical history, clinical testing results about their diabetes complication, and make a comprehensive assessment of their cardiovascular and cerebrovascular risks. These data will be used to make further research about the diabetes complication and cardiovascular and cerebrovascular disease.

Interventions

OTHERno intervention

no intervention

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diabetic symptoms with: plasma glucose level at any time ≥11.1mmol/ L (200mg/ dL), or Fasting plasma glucose level ≥7.0mmol/ L (126mg/ dL), or plasma glucose level ≥11.1mmol/ L (200ng/ dL) for 2 h in OGTT test, or HbA1c ≥6.5%; Or those without typical symptoms should repeated the tests in another day. * Han Chinese. * Willingness to participate.

Exclusion criteria

* Secondary diabetes. * Participants in other clinical trials.

Design outcomes

Primary

MeasureTime frameDescription
Framingham Risk Scose1 weekThe Framingham risk score calculates an individual's risk of coronary heart disease over the next 10 years based on cholesterol levels and non-cholesterol factors. Non-cholesterol factors are subdivided into risk factors, major risk factors, and other factors. Risk factors include: diabetes; evidence of coronary heart disease; evidence of atherosclerosis outside the heart. Major risk factors include: male older than 45 years old, female older than 55 years old; Smoking; Hypertension (higehr than 140/90mmHg or being treated for hypertension); High-density lipoprotein lower than 40 mg/dl; First-degree relatives, male younger than 55 years old, or female younger than 65 years old, with a history of coronary heart disease. A higher score corresponds to a higher 10-year risk of developing cardiovascular disease.
UK Prospective Diabetes Study risk score1 weekThis scale provides an estimate of the risks for a new coronary heart disease(CHD) event and stroke (fatal and nonfatal). The data used to calculate the UK Prospective Diabetes Study(UKPDS) risk scores (available at http://www.dtu.ox.ac.uk/riskengine/download.php) included HbA1c, systolic blood pressure, serum total cholesterol and HDL-C, atrial fibrillation, sex, age, ethnicity, smoking status, and diabetes duration. The risks of CHD, fatal CHD, stroke, and fatal stroke were estimated for 10 years. A higher score corresponds to a higher 10-year risk of developing cardiovascular disease.

Countries

China

Contacts

Primary ContactPengfei Shan, MD, PhD
pengfeishan@zju.edu.cn+86 13958039665

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026