Newly Diagnosed Type 1 and Type 2 Diabetes and PrediabetesNCT05401708
A Prospective Cohort Study for Establishing Clinical Excellence in Patients With Newly Diagnosed Type 1 and Type 2 Diabetes and Prediabetes
An observational study of Newly Diagnosed Type 1 and Type 2 Diabetes and Prediabetes, run by Yonsei University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Newly Diagnosed Type 1 and Type 2 Diabetes and Prediabetes
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2022to May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
BYEONGWAN LEE, +82 2 2228-1938, BWANLEE@yuhs.ac
About this study
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.
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DM Naïve | a new patient without a history of DM medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Annually for 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study startJul 2022 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Type 1 and Type 2 Diabetes and PrediabetesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BYEONGWAN LEE, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401708
- Sponsor's protocol ID
- 4-2022-0234
- Status last verified
- May 2022
- First submitted
- 29 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study for Establishing Clinical Excellence in Patients With Newly Diagnosed Type 1 and Type 2 Diabetes and Prediabetes
- ClinicalTrials.gov ID
- NCT05401708
- Acronym / sponsor ID
- 4-2022-0234
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DM Naïve | – | –a new patient without a history of DM medication |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between blood and urinary tests and complications in patients with type 1 and 2 diabetes mellitus and prediabetes (cross-sectional)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BYEONGWAN LEE principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newly Diagnosed Type 1 and Type 2 Diabetes and Prediabetes, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BYEONGWAN LEE (+82 2 2228-1938, BWANLEE@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between blood and urinary tests and complications in patients with type 1 and 2 diabetes mellitus and prediabetes (cross-sectional) (time frame: Annually for 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.