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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035615
Receipt No. R000040275
Scientific Title Effects of glucose and blood pressure variability on oxidative stress in patients with type 2 diabetes mellitus and hypertension: A cross-sectional study
Date of disclosure of the study information 2019/02/01
Last modified on 2019/01/20

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Basic information
Public title Effects of glucose and blood pressure variability on oxidative stress in patients with type 2 diabetes mellitus and hypertension: A cross-sectional study
Acronym Effects of glucose and blood pressure variability on oxidative stress in patients with type 2 diabetes mellitus and hypertension: A cross-sectional study
Scientific Title Effects of glucose and blood pressure variability on oxidative stress in patients with type 2 diabetes mellitus and hypertension: A cross-sectional study
Scientific Title:Acronym Effects of glucose and blood pressure variability on oxidative stress in patients with type 2 diabetes mellitus and hypertension: A cross-sectional study
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 glucose and blood pressure (BP) variability on oxidative stress in patients with type 2 diabetes mellitus (T2DM) and hypertension.
Basic objectives2 Others
Basic objectives -Others cross-sectional study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the relationship between oxidative stress and glucose and BP variability in patients with type 2 diabetes mellitus and hypertension
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 Hospitalized type 2 diabetes mellitus and hypertension
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)secondary hypertension,
9)Patients who are judged as inappropriate for inclusion by phsicians
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Ohara
Organization Showa University School of Medicine
Division name Division of Diabetes and Endocrinology, Department of Internal Medicine
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 0337848000
Email s6018@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Ohara
Organization Showa University School of Medicine
Division name Division of Diabetes and Endocrinology, Department of Internal Medicine
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 0337848000
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
Address
Tel
Email

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
2019 Year 02 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
2015 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We performed a cross-sectional study including 60 inpatients with T2DM and hypertension who were treated at Showa University Hospital from June 2015 to January 2018.

Management information
Registered date
2019 Year 01 Month 22 Day
Last modified on
2019 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040275

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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