UMIN-CTR Clinical Trial

Basic information
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
Condition	type 2 diabetes.
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
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

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 (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

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	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

Research contact person
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

Public contact
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

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

Funding Source
Organization	Simazu Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
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	2022 Year 05 Month 30 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	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

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

Management information
Registered date	2022 Year 05 Month 13 Day
Last modified on	2022 Year 05 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054435