Diabetes Complications and the Risk of Cardiovascular and Cerebrovascular Diseases

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04983277
• Other study ID #: DCRCCD
• Status: Not yet recruiting
• Start date: July 2021
• Est. completion date: December 2030

Study information

• Verified date: July 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Pengfei Shan, MD, PhD
• Phone: +86 13958039665
• Email: pengfeishan[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: December 2030
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cerebrovascular Disease
• Cerebrovascular Disorders
• Diabetes Complications
• Diabetes Mellitus

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Framingham Risk Scose	The 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.	1 week
Primary	UK Prospective Diabetes Study risk score	This 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.	1 week