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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Diabetes Complications; Cerebrovascular Disease
• Intervention / Treatment: Other: no intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Pengfei Shan, MD, PhD; Phone Number: +86 13958039665; Email: pengfeishan@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with diagnosis of diabetes mellitus

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetes; patients with diagnosed Diabetes Mellitus	Other: no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Pengfei Shan, MD, PhD, Department of Endocrinology and Metabolism, Second Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: July 11, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): July 30, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus; Cerebrovascular Disorders; Diabetes Complications
• Other Study ID Numbers: DCRCCD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No