A multicenter prospective observational pilot study on the relationship between patient fingertip AGE measurements, body composition, and blood glucose fluctuations measured by continuous blood glucose monitoring in patients with type 2 diabetes.

A multicenter prospective observational pilot study on the relationship between fingertip AGE measurements, body composition and fluctuations of blood glucose in type 2 diabetes mellitus. - A multicenter prospective observational pilot study on the relationship between fingertip AGE measurements and physical constitution in type 2 diabetes.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053692

Enrollment

200

Registered

2024-02-23

Start date

2023-10-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The target number of cases for all participating facilities is 200. Patients diagnosed with type 2 diabetes based on the Japan Diabetes Society's Diabetes Treatment Guide 2016-2017 and receiving regular treatment on an outpatient or inpatient basis. Subjects will be those who match the selection criteria as below. 1. Type 2 diabetic patients over 20 years old. 2. Regardless of gender.

Exclusion criteria

Exclusion criteria: 1. Cases with obvious infection. 2. Cases of obvious chronic inflammatory diseases such as autoimmune diseases, or cases of long-term use of steroid drugs for treatment. 3. Cases diagnosed with advanced cancer. 4. Fresh case of cerebrovascular accident (within 12 weeks of onset). 5. Cases with liver dysfunction (ALT > 3 x facility upper limit). 6. Cases with complications that are judged to seriously impede the conduct of the study, such as respiratory disease, poorly controlled heart failure, or arrhythmia. 7. Cases with a history of alcoholism or drug addiction, or cases with psychosis or psychotic symptoms that make it difficult to participate in the study. 8. In other cases where the doctor in charge of the study determines that the subject is unsuitable for the safe conduct of this study.

Design outcomes

Primary

Measure	Time frame
The relationship between the initial value and amount of change in AGE score and the development and progression of micro/macrovascular complications and cognitive dysfunction.	—

Secondary

Measure	Time frame
1. Relationship between the initial value of AGE score and its amount of change and the initial value and amount of change of blood sugar fluctuation index 2. Relationship between the initial value of AGE score and the amount of change thereof and various measured values of the body composition analyzer 3. Relationship between the initial value of AGE score and its amount of change and the change in DASK-8 evaluation value 4. Relationship between the initial value and amount of change of the blood sugar fluctuation index and various measured values of the body composition analyzer 5. Relationship between the initial value and amount of change in the blood sugar fluctuation index and the transition of the DASK-8 evaluation value 6. Relationship between the initial value and amount of change in various measured values of the body composition analyzer and the transition of the DASK-8 evaluation value 7. Relationship between development of large and small vessel complications and each parameter 8. Relationship between cognitive function decline and each parameter	—

Measure

Time frame

1. Relationship between the initial value of AGE score and its amount of change and the initial value and amount of change of blood sugar fluctuation index 2. Relationship between the initial value of AGE score and the amount of change thereof and various measured values of the body composition analyzer 3. Relationship between the initial value of AGE score and its amount of change and the change in DASK-8 evaluation value 4. Relationship between the initial value and amount of change of the blood sugar fluctuation index and various measured values of the body composition analyzer 5. Relationship between the initial value and amount of change in the blood sugar fluctuation index and the transition of the DASK-8 evaluation value 6. Relationship between the initial value and amount of change in various measured values of the body composition analyzer and the transition of the DASK-8 evaluation value 7. Relationship between development of large and small vessel complications and each parameter 8. Relationship between cognitive function decline and each parameter

—

Countries

Japan

Contacts

Public ContactTakeshi Matsumura

Faculty of Life Sciences, Kumamoto University Department of Metabolic Medicine

takeshim@gpo.kumamoto-u.ac.jp0963735169

Outcome results