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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Newly Diagnosed Type 1 and Type 2 Diabetes and Prediabetes

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

Contacts and Locations

• Study Contact: Name: BYEONGWAN LEE; Phone Number: +82 2 2228-1938; Email: BWANLEE@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University Health System, Severance Hospital
    • Contact: BYEONGWAN LEE; Phone Number: +82 2 2228-1938; Email: BWANLEE@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who visited Severance hospital from March, 2022 with newly diagnosed type 1 diabetes/type 2 diabetes or prediabetes and consented and underwent regular blood and urinary tests acccording to the current guidelines Inclusion criteria

• 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.

Exclusion criteria 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)

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
DM Naïve; a new patient without a history of DM medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between blood and urinary tests and complications in patients with type 1 and 2 diabetes mellitus and prediabetes (cross-sectional)	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	Annually for 5 years.

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: BYEONGWAN LEE, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): May 1, 2026
• Study Completion (Anticipated): May 1, 2026

Study Registration Dates

• First Submitted: May 29, 2022
• First Submitted That Met QC Criteria: May 29, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 29, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: 4-2022-0234

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