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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041818
Receipt No. 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 2021/06/28

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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
Email 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
Email s6018@nms.ac.jp

Sponsor
Institute Showa University School of Medicine, Division of Diabetes and Endocrinology, Department of Internal Medicine
Institute
Department

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
Email 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 Enrolling by invitation
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
2021 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043852

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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