Diabetes Complications and the Risk of Cardiovascular and Cerebrovascular Diseases

NCT04983277 | Not Yet Recruiting

• 1 other identifier: DCRCCD
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Complications; Cardiovascular Diseases; Cerebrovascular Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Diabetes

patients with diagnosed Diabetes Mellitus

Other: no intervention

Interventions

no intervention OTHER

no intervention

Diabetes

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

patients with diagnosis of diabetes mellitus

You may qualify if:

• 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.

You may not qualify if:

• Secondary diabetes.
• Participants in other clinical trials.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood and urine

MeSH Terms

Conditions

Diabetes Complications; Cardiovascular Diseases; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Pengfei Shan, MD, PhD

  Department of Endocrinology and Metabolism, Second Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengfei Shan, MD, PhD

CONTACT

+86 13958039665; pengfeishan@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: July 30, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)