UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015966 |
|---|---|
| Receipt number | R000018573 |
| Scientific Title | Clinical benefit of measurement of advanced glycogen endproduct level in type 2 diabetes |
| Date of disclosure of the study information | 2014/12/16 |
| Last modified on | 2023/09/14 06:45:12 |
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Basic information
Public title
Clinical benefit of measurement of advanced glycogen endproduct level in type 2 diabetes
Acronym
Clinical benefit of measurement of advanced glycogen endproduct level in type 2 diabetes
Scientific Title
Clinical benefit of measurement of advanced glycogen endproduct level in type 2 diabetes
Scientific Title:Acronym
Clinical benefit of measurement of advanced glycogen endproduct level in 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
Te aim of the study is to investigate the level of advanced glycogen endproduct (AGE), and its correlation with macro- and micro-angiopathy in patient with type 2 diabetes.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between serum level of several AGE constructs, including N-(carboxymethyl)lysine(CML), N-(carboxyethyl)lysine(CEL), S-(2-Succinyl)cysteine(2SC), Carboxymethyl-arginine(CMA), Carboxyethyl-arginine(CEA), Methylglyoxal-Imidazolone (MG-Imidazolone), Glucoselisine (GL), N-(5-hydro-5-methyl-4-imidazolon-2-yl) ornithine (MG-H1), and other experimental markers for macro- and micro-angiopathy (leukocyte counts, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, total protein, serum albumin, serum creatinin, BUN, UA, AST, ALT, LDH, CHE, ALP, g-GTP, total bilirubin, creatin kinase, fasting glucose level, fasting serum insulin level, HbA1c, hs-CRP, systatin-C, urinaly albumin level, urinaly creatinin, urinaly L-FABP, mean- and max-IMT, baPWV, TNFa, IL-1b, IL-6, adiponectin, sICAM-1, E-serectin, endothelin-1, mean- and MAX-IMT, baPWV, degree of retinopathy, degree of neuropathy and degree of nephropathy ). We also investigate correlation between amounts of AGE constructs and degree of autofluorescence by irradiation of light. Moreover, we investigate correlation between amounts of AGE constructs and the presence of micro- and macro-vascular complications.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
We will recruited 200 patients with type 2 diabetes who were hospitalized for glycemic control in Kumamoto University Hospital.
Key exclusion criteria
1. Patients with infectious disease
2. Patients with acute/chronic inflammatory disease
3. Patients with cancer
4. Patients with acute cerebrovascular disease
5. Patients with severe hepatic disease
6. Patients with severe respiratory
7. Patients with mental disorder
8. Patients decided from attended doctors not to be recruited in the study
Target sample size
200
Research contact person
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, 860-8556, Japan
TEL
0963735169
takeshim@gpo.kumamoto-u.ac.jp
Public contact
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
8608856
Address
1-1-1 Honjo, Chuo, Kumamoto, Kumamoto
TEL
096-373-5169
Homepage URL
takeshim@gpo.kumamoto-u.ac.jp
Sponsor or person
Institute
Human Ethics Review Committee of Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
This work was supported by a Grant-in-Aid for Scientific Research from the Japan Society for the Promotion of Science, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Laboratory of Food and Regulation Biology, Department of Bioscience, School of Agricalture, Tokai University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Ethics Review Committee of Kumamoto University
Address
1-1-1 Honjo, Chuo, Kumamoto, 860-8556, Japan
Tel
096-373-5657
ski-shien@jimu.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
熊本大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Main factor in the study:
Measurement of serum AGE.
Subjects:Type 2 diabetes
Management information
Registered date
| 2014 | Year | 12 | Month | 16 | Day |
Last modified on
| 2023 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018573
