UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041818 |
|---|---|
| Receipt number | R000043852 |
| Scientific Title | Relationship between short-, intermediate- and long-term glucose variability and oxidative stress in type 2 diabetes |
| Date of disclosure of the study information | 2021/01/01 |
| Last modified on | 2022/01/04 01:22:19 |
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Basic information
Public title
Relationship between short-, intermediate- and long-term glucose variability and oxidative stress in type 2 diabetes
Acronym
Relationship between short-, intermediate- and long-term glucose variability and oxidative stress in type 2 diabetes
Scientific Title
Relationship between short-, intermediate- and long-term glucose variability and oxidative stress in type 2 diabetes
Scientific Title:Acronym
Relationship between short-, intermediate- and long-term glucose variability and oxidative stress in type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluated the effects of short-, intermediate- and long-term glucose variabilities on oxidative stress in patients with type 2 diabetes mellitus.
Basic objectives2
Others
Basic objectives -Others
cross-sectional study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the relationship between short-, intermediate- and long-term glucose variabilities and oxidative stress in patients with type 2 diabetes mellitus
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
outpatients of type 2 diabetes mellitus
Key exclusion criteria
1)the use of steroids or anti-inflammatory drugs,
2)diabetic ketosis and coma within 3 months before the study,
3)severe infection, severe trauma, pre-and post-operation,
4)an estimated glomerular filtration rate are within 30mL/min/1.73m2,
5)severe liver dysfunction,
6)malignancy,
7)pregnancy,
8)Patients who are judged as inappropriate for inclusion by phsicians
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ohara |
Organization
Showa University School of Medicine
Division name
Division of Diabetes and Endocrinology, Department of Internal Medicine
Zip code
142-8888
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
0337848129
s6018@nms.ac.jp
Public contact
Name of contact person
| 1st name | ohara |
| Middle name | |
| Last name | makoto |
Organization
Showa University School of Medicine
Division name
Division of Diabetes and Endocrinology, Department of Internal Medicine
Zip code
142-8888
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
0337848129
Homepage URL
s6018@nms.ac.jp
Sponsor or person
Institute
Showa University School of Medicine, Division of Diabetes and Endocrinology, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Showa University School of Medicine, Division of Diabetes and Endocrinology, Department of Internal Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics comittee specializing in human subgects reserch at the Showa University
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
0337848129
s6018@nms.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
| 2021 | Year | 01 | Month | 01 | 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
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2020 | Year | 09 | Month | 17 | Day |
Last modified on
| 2022 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043852
