UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059540 |
|---|---|
| Receipt number | R000068029 |
| Scientific Title | Association between long-term metabolic parameters and advanced glycation end products accumulation in patients with type 2 diabetes |
| Date of disclosure of the study information | 2025/10/27 |
| Last modified on | 2025/10/26 09:07:06 |
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Basic information
Public title
Association between long-term metabolic parameters and advanced glycation end products accumulation in patients with type 2 diabetes
Acronym
Association between long-term metabolic parameters and advanced glycation end products accumulation in patients with type 2 diabetes
Scientific Title
Association between long-term metabolic parameters and advanced glycation end products accumulation in patients with type 2 diabetes
Scientific Title:Acronym
Association between long-term metabolic parameters and advanced glycation end products accumulation in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between the accumulation of advanced glycation end products (AGEs) assessed by skin autofluorescence (SAF) and long-term glycemic indices (mean levels and variability of HbA1c) over the past eight years.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ohara |
Organization
Showa Medical University Graduate School of Medicine
Division name
Division of Diabetes, Metabolism, and Endocrinology, Department of Medicine
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8000
s6018@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ohara |
Organization
Showa Medical University School of Medicine
Division name
Division of Diabetes, Metabolism, and Endocrinology, Department of Medicine
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8685
Homepage URL
s6018@med.showa-u.ac.jp
Sponsor or person
Institute
Showa Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Showa Medical University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa Medical University Research Ethics Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8129
m-rinri@ofc.showa-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we will examine the relationship between SAF and HbA1c, LDL cholesterol, and systolic blood pressure in patients with type 2 diabetes using longitudinal data on HbA1c, LDL cholesterol, and systolic blood pressure stored in electronic medical records for the past eight years.
Management information
Registered date
| 2025 | Year | 10 | Month | 26 | Day |
Last modified on
| 2025 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068029
