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NCT Number: NCT04983277

Diabetes 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.

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Key information

Conditions

Diabetes Complications Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disease Cerebrovascular Disorders Diabetes Mellitus Endocrine System Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. Framingham Risk Scose

    Time frame: 1 week

    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.

  2. UK Prospective Diabetes Study risk score

    Time frame: 1 week

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pengfei Shan, MD, PhD

CONTACT

[email protected]

+86 13958039665

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2030
First posted
Jul 30, 2021
Registry last updated
Jul 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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