Tokyo, Oct. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059540) titled 'Association between long-term metabolic parameters and advanced glycation end products accumulation in patients with type 2 diabetes' on Oct. 27.
Study Type:
Observational
Primary Sponsor:
Institute - Showa Medical University School of Medicine
Condition:
Condition - Type 2 Diabetes
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to clarify the association between the mean levels and variability of long-term metabolic parameters, including glycemia (HbA1c), lipid profile (LDL cholesterol), and blood pressure (systolic blood pressure; SBP), over the past eight years and the accumulation of advanced glycation end products (AGEs) assessed by skin autofluorescence (SAF) in patients with type 2 diabetes.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1.Patients attending the outpatient clinics of the Department of Diabetes, Metabolism and Endocrinology, Showa Medical University Hospital, and the Nagareyama Central Park Ekimae Clinic affiliated with Tokatsu Hospital.
2.Patients aged 18 years or older who have been diagnosed with type 2 diabetes according to the diagnostic criteria.
3.Patients in whom skin autofluorescence (SAF) measurement can be performed.
4.Patients with regularly recorded data on glycemia (HbA1c), lipid profile (LDL cholesterol), and systolic blood pressure (SBP) in electronic medical records for at least the past eight years.
5.Patients who have received a full explanation of the study and have provided written informed consent voluntarily.
Key exclusion criteria - 1.Patients diagnosed with type 1 diabetes, gestational diabetes, or other specific types of diabetes with known etiologies (e.g., pancreatic diabetes, steroid-induced diabetes).
2.Patients with skin disorders that may affect SAF measurement (e.g., marked pigmentation, inflammatory disease, or scars) at the measurement site (forearm).
3.Patients with insufficient regular records of HbA1c, LDL cholesterol, or systolic blood pressure during the past eight years.
4.Patients who are judged to have difficulty understanding the study or providing consent for data use.
5.Patients who are deemed inappropriate for inclusion in this study by the principal investigator or attending physician.
Target Size - 200
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 20 Day
Date of IRB - 2025 Year 10 Month 20 Day
Anticipated trial start date - 2025 Year 10 Month 20 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068029
Disclaimer: Curated by HT Syndication.