UMIN-CTR Clinical Trial

Public title

Relationship between advanced glycogen endproduct level measured by non-invasive fluorescent AGE analyzer and FGM-monitored glycemic fluctuations in type 2 diabetes

Acronym

Relationship between advanced glycogen endproduct level measured by non-invasive fluorescent AGE analyzer and FGM-monitored glycemic fluctuations in type 2 diabetes

Scientific Title

Relationship between advanced glycogen endproduct level measured by non-invasive fluorescent AGE analyzer and FGM-monitored glycemic fluctuations in type 2 diabetes

Scientific Title:Acronym

Relationship between advanced glycogen endproduct level measured by non-invasive fluorescent AGE analyzer and FGM-monitored glycemic fluctuations in type 2 diabetes

Region

Japan

Condition

type 2 diabetes.

Classification by specialty

Cardiology

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to investigate the correlation between the AGE measurement value using the fingertip AGE sensor and the blood glucose fluctuation range or the number and time of hypoglycemia in patients with type 2 diabetes.

Basic objectives2

Bio-availability

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The correlation between the AGE measurement value using the fingertip AGE sensor and the blood glucose fluctuation range or the number and time of hypoglycemia

Key secondary outcomes

1: Correlation between AGE measurements using the fingertip AGE sensor and various parameters as follow;
1. fasting plasma glucose
2. HbA1c
3. glycated albumin
4. systolic blood pressure
5. diastolic blood pressure
6. serum lipid profiles
7. eGFR (ml/min/1.73m2)
8. Liver function: AST, ALT, GGT
9. weight, BMI
10. serum Albumin
11. ACR(Urinary-albumin/creatinine ratio)
12. T-Bil
13. HOMA-R
14. hs-CRP
15. mean-IMT, max-IMT, plaque score
16. ABI, baPWV
17. counts of leukocyte and its fraction
18. history of retinopathy, neuropathy and nephropathy
19. history of coronary artery disease, cerebrovascular disease and peripheral artery disease
20. medication profiles

2: Correlation between blood glucose fluctuation range analyzed by FGM and various parameters as follow;
1. fasting plasma glucose
2. HbA1c
3. glycated albumin
4. systolic blood pressure
5. diastolic blood pressure
6. serum lipid profiles
7. eGFR (ml/min/1.73m2)
8. Liver function: AST, ALT, GGT
9. weight, BMI
10. serum Albumin
11. ACR(Urinary-albumin/creatinine ratio)
12. T-Bil
13. HOMA-R
14. hs-CRP
15. mean-IMT, max-IMT, plaque score
16. ABI, baPWV
17. counts of leukocyte and its fraction
18. history of retinopathy, neuropathy and nephropathy
19. history of coronary artery disease, cerebrovascular disease and peripheral artery disease
20. medication profiles

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 selection criteria for the subjects are as follow.
1. Patients who have been diagnosed as type 2 diabetes.
2. Regardless of gender

Key exclusion criteria

The exclusion criteria for the subjects are as follow.
1. Subjects with acute and/or chronic inflammation
2. Subjects with fresh cardiovascular and/or cerebrovascular diseases
3. Subjects with liver cirrhosis.
4. Subjects with severe respiratory disease or severe heart failure
5. Subjects with alcoholicsm or medicinal intoxication
6. Subjects with psychosis
7. Subjects who doctors judge as unfitness

Target sample size

80

Name of lead principal investigator

1st name	Takeshi
Middle name
Last name	Matsumura

Organization

Kumamoto University

Division name

Department of Metabolic Medicine, Faculty of life sciences

Zip code

860-8556

Address

1-1-1 Honjyo, 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

Kumamoto University

Division name

Department of Metabolic Medicine, Faculty of Life Sciences

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

Organization

Simazu Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Metabolic Medicine, Faculty of Life Sciences, Kumamoto University

Address

1-1-1 Honjyo, Chuo, Kumamoto Kumamoto, Japan

Tel

0963735169

Email

takeshim@gpo.kumamoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

05

Month

30

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

Preinitiation

Date of protocol fixation

2022

Year

05

Month

13

Day

Date of IRB

Anticipated trial start date

2022

Year

07

Month

01

Day

Last follow-up date

2025

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Objectives
The aim of this study is to investigate the correlation between the AGE measurement value using the fingertip AGE sensor and the blood glucose fluctuation range or the number and time of hypoglycemia in patients with type 2 diabetes.

Assessment
Primary outcomes
The correlation between the AGE measurement value using the fingertip AGE sensor and the blood glucose fluctuation range or the number and time of hypoglycemia

Key secondary outcomes
1: Correlation between AGE measurements using the fingertip AGE sensor and various parameters as follow;
1. fasting plasma glucose
2. HbA1c
3. glycated albumin
4. systolic blood pressure
5. diastolic blood pressure
6. serum lipid profiles
7. eGFR
8. Liver function; AST, ALT, GGT
9. weight, BMI
10. serum Albumin
11. ACR(Urinary-albumin/creatinine ratio)
12. T-Bil
13. HOMA-R
14. hs-CRP
15. mean-IMT, max-IMT, plaque score
16. ABI, baPWV
17. counts of leukocyte and its fraction
18. history of retinopathy, neuropathy and nephropathy
19. history of coronary artery disease, cerebrovascular disease and peripheral artery disease
20. medication profiles

2: Correlation between blood glucose fluctuation range analyzed by FGM and various parameters as follow;
1. fasting plasma glucose
2. HbA1c
3. glycated albumin
4. systolic blood pressure
5. diastolic blood pressure
6. serum lipid profiles
7. eGFR (ml/min/1.73m2)
8. Liver function; AST, ALT, GGT
10. serum Albumin
11. ACR(Urinary-albumin/creatinine ratio)
12. T-Bil
13. HOMA-R
14. hs-CRP
15. mean-IMT, max-IMT, plaque score
16. ABI, baPWV
17. counts of leukocyte and its fraction
18. history of retinopathy, neuropathy and nephropathy
19. history of coronary artery disease, cerebrovascular disease and peripheral artery disease
20. medication profiles

Registered date

2022

Year

05

Month

13

Day

Last modified on

2022

Year

05

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054435