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临床试验/NCT05401708
NCT05401708尚未招募不适用

A Prospective Cohort Study for Establishing Clinical Excellence in Patients With Newly Diagnosed Type 1 and Type 2 Diabetes and Prediabetes

Yonsei University1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2022年7月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
3,000
试验地点
1
主要终点
Correlation between blood and urinary tests and complications in patients with type 1 and 2 diabetes mellitus and prediabetes (cross-sectional)

研究概览

简要总结

Diabetes mellitus is recognized as a metabolic disease that causes global economic and health burdens with an estimated number of patients 135 million in 1995 to 300 million in 2025. Moreover, the Asia-Pacific region is considered to be on the verge of an emerging diabetes epidemic. Diabetes is associated with numerous comorbidities due to a wide range of complications, such as retinopathy, nephropathy, neuropathy, and cardiovascular disease, which could lead to premature mortality. Management of diabetes under standard treatment protocol improves quality of life and prevents complications and premature mortality. Pathogenesis of these detrimental complications caused by diabetes is not yet discovered and it is important to reveal epidemiology and mechanisms of diabetes and its complications in order to successfully manage and control diabetes. According to the Committee of the Korean Diabetes Association on the Epidemiology of Diabetes Mellitus, only about one third of patients with diabetes was found to reach target glycemic control (<7% of HbA1c) and 30.3%, 38.3% and 44.6% of patients found to have microalbuminuria, retinopathy and nephropathy, respectively in tertiary hospitals of Korea in 2006. Also, prevalence of coronary artery disease, cerebrovascular disease and peripheral artery disease was 8.7%, 6.75 and 3.0%, respectively in tertiary hospitals. Due to inadequate achievement of glycemic control and improper prevention tactics to prevent diabetic complication for patients in tertiary hospitals in Korea, it is pivotal to determine and analyze the current status of patients with diabetes and prediabetes for efficient management of diabetes/prediabetes and its complications. Annual visits of newly diagnosed diabetes or prediabetes to Endocrinology department of Severance hospital in Korea are increasing, about 5,000 patients per year since 2017. However, there is no current systemic clinical registry involving patients with diabetes or prediabetes in Severance hospital. Therefore, in this prospective cohort study, we will establish registry for patients with diabetes or prediabetes who would perform standard blood/urine tests and follow treatment protocols in Endocrinology department of Severance hospital.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Drug naive patients who are newly diagnosed type 1 diabetes/type 2 diabetes or prediabetes since March, 2022 in Severance hospital ② Male or female who are older than 20 years ③ Patients who consented and underwent recommended regular blood and urinary tests according to the current guidelines.

排除标准

  • ① Patients who are considered to be unable to participate in the study by the judgement of researchers
  • ② Patients who are unable to read the consent forms (E.g Foreigner, illiteracy)

结局指标

主要结局

Correlation between blood and urinary tests and complications in patients with type 1 and 2 diabetes mellitus and prediabetes (cross-sectional)

时间窗: Annually for 5 years.

Blood and urinary samples : fasting glucose/insulin/c-peptide, HbA1c, glycoalbumin, beta-hydroxybutyrate, free fatty acid-fasting, postprandial 90 min glucose/insulin/c-peptide, BUN, creatinine, eGFR, AST, ALT, ALP, GGT, total bilirubin, total protein, albumin, uric acid, total cholesterol, triglyceride, HDL, LDL, WBC, RBC, hemoglobin, hematocrit, platelet, c-reactive protein, urine Glucose, Creatinine, Microprotein, total, Microalbumin, Urinalysis with Microscopy, Urinary N-acetyl beta-D glucosaminidase Complication study: Liver Fibroscan, fundoscopy, Intima media thickness, Nerve conduction velocity, Fat u/s \& Body Index, Pulse wave velocity \& ankle brachial index, Autonomic nervous system

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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