UMIN-ICDS Clinical Trial

Public title

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.

Acronym

Relationship between fingertip AGE measurements, body composition and fluctuations of blood glucose in patients with type 2 diabetes mellitus; A multicenter prospective observational pilot study.

Scientific Title

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.

Scientific Title:Acronym

A multicenter prospective observational pilot study on the relationship between fingertip AGE measurements and physical constitution in type 2 diabetes.

Region

Japan

Condition

Type 2 Diabetes Mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Diabetic vascular complications are serious complications. Clinical trials have indicated that HbA1c, an index of chronic hyperglycemia, is well correlated with the onset and progression of several vascular complications. On the other hand, in recent years, it has been suggested that factors related to the constitution and quality of blood glucose, such as obesity due to visceral fat accumulation, decreased muscle mass, hypertension, and blood glucose fluctuations, are involved in the onset and progression of vascular complications and dementia. In diabetes, advanced glycation end products (AGEs) are associated with diabetic micro- and macrovascular complications and dementia. Previous reports have shown that the increase in blood AGEs level is correlated with the duration of diabetes, the presence of diabetic microvascular complications, and the onset of arteriosclerosis. We developed an AGE sensor that can non-invasively measure skin AGE content in fingertips, and we reported that there was a significant positive correlation between the fluorescence intensity obtained with the AGE sensor and the prevalence of diabetic microvascular complications (J Clin Biochem Nutr. 58(2):135-140, 2016. ). On the other hand, there are still no reports on the relationship between the values measured by this AGE sensor and factors related to physical constitution, blood glucose control and its quality. Moreover, no one knows the relationship between these factors and the development and progression of vascular complications and dementia.
This study aimed to investigate the relationship between the values measured by the fingertip AGE sensor and various body composition values measured by a body composition analyzer, the blood glucose fluctuation index measured by continuous glucose monitoring (CGM) in type 2 diabetic patients. Furthermore, we examine the relationship between above factors and micro/macrovascular complications and dementia.

Basic objectives2

Bio-availability

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

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.

Key secondary outcomes

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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.

Key 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.

Target sample size

200

Name of lead principal investigator

1st name	Takeshi
Middle name
Last name	Matsumura

Organization

Faculty of Life Sciences, Kumamoto University

Division name

Department of Metabolic Medicine

Zip code

860-8556

Address

1-1-1 Honjo, Chuo, Kumamoto, Kumamoto, Japan

TEL

0963735169

Email

takeshim@gpo.kumamoto-u.ac.jp

Name of contact person

1st name	Takeshi
Middle name
Last name	Matsumura

Organization

Faculty of Life Sciences, Kumamoto University

Division name

Department of Metabolic Medicine

Zip code

860-8556

Address

1-1-1 Honjo, Chuo, Kumamoto, Kumamoto, Japan

TEL

0963735169

Homepage URL

Email

takeshim@gpo.kumamoto-u.ac.jp

Institute

Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University

Institute

Department

Personal name

Takeshi Matsumura

Organization

Self-funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Shimadzu Corporation

Name of secondary funder(s)

Organization

Human Ethics Review Committee of Kumamoto University

Address

1-1-1 Honjo, Chuo, Kumamoto 860-8556, Japan

Tel

0963735657

Email

ski-shien@jimu.kumamoto-u.ac.jp

Secondary IDs

YES

Study ID_1

2747

Org. issuing International ID_1

Human Ethics Review Committee of Kumamoto University

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

熊本大学大学院生命科学研究部代謝内科学講座（熊本県）
医療法人財団 聖十字会 西日本病院（熊本県）
株式会社　島津製作所（京都府）
あそうクリニック（静岡県）

Date of disclosure of the study information

2024

Year

02

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2023

Year

05

Month

06

Day

Date of IRB

2023

Year

06

Month

15

Day

Anticipated trial start date

2023

Year

10

Month

19

Day

Last follow-up date

2026

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1) Type of sample: Blood (approximately 5 to 10 mL: similar amount used in general health checkups)
2) Type of information:
[Basic survey items]
Age, gender, height, weight, BMI, presence of diabetic microvascular complications and their stage classification, presence of diabetic macrovascular complications, presence of dementia, smoking history, dulation of diabetes, drug information.
[Blood test items]
Hemogram test, blood image test (white blood cell differential)
Total cholesterol (TC), LDL-C, HDL-C, TG, total protein, albumin, creatinine, BUN, uric acid, AST (GOT), ALT
(GPT), LDH, CHE, ALP, GGT, total bilirubin, CK (CPK), fasting blood glucose level, fasting blood insulin, HbA1c,
GA, hs-CRP, urinary albumin, urinary creatinine
[Image inspection items]
Carotid artery ultrasound examination (IMT measurement: mean CCA-IMT, max CCA-IMT, Plaque score)
Fundus examination (stage evaluation performed by each department or ophthalmology consultant)
[Physiological test items]
blood pressure measurement
Measuring baPWV
R-R interval
Orthostatic test
Vibration sensation test
achilles tendon reflex
nerve conduction velocity
[Inspection using AGE sensor]
Excited autologous cells are excited by irradiating the tip of the middle finger of the opposite hand with light with a wavelength of 365 nm at an intensity of <150 to 300 mW/cm2. Measure the intensity of fluorescence from 440 to 470 nm.
[CGM inspection using freestyle Libre]
Measurement of blood glucose variability index (MAGE, SD, CV, TIR < TAR, TBR, eHbA1c).
[Test using body component analyzer (Inbody)]
Measurement of body fat mass, visceral fat mass, muscle mass, skeletal muscle mass, estimated waist circumference, and basal metabolic rate.
[Survey using daily functioning questionnaire (DASK-8)]
Presence of dementia and evaluation of cognitive function with DASK-8

Registered date

2024

Year

02

Month

23

Day

Last modified on

2024

Year

02

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060968