UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000036639
Receipt No. R000041739
Scientific Title Relationship between short-term glycemic and blood pressure variability in patients with type 2 diabetes
Date of disclosure of the study information 2019/05/02
Last modified on 2019/05/02 (Ver. 1)

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Basic information
Public title Relationship between short-term glycemic and blood pressure variability in patients with type 2 diabetes
Acronym Relationship between short-term glycemic and blood pressure variability
Scientific Title Relationship between short-term glycemic and blood pressure variability in patients with type 2 diabetes
Scientific Title:Acronym Relationship between short-term glycemic and blood pressure variability
Region
Japan

Condition
Condition type 2 diabetes diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the Relationship between short-term glucose Variability and short-term blood pressure Variability in type 2 DM patients (retrospective)
Basic objectives2 Others
Basic objectives -Others none
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The Relationship between 24-h glucose Variability and blood pressure Variability
Key secondary outcomes none

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
80 years-old >
Gender Male and Female
Key inclusion criteria inpatients type 2 diabetic subjects that went through CGM, ABPM during their hospitalization.
Key exclusion criteria Patients who underwent glucose infusions during CGM were excluded considering the effects for BPV
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name Masaya
Middle name
Last name Sakamoto
Organization ikei University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code 105-8461
Address 3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Email m-sakamoto@umin.ac.jp

Public contact
1st name of contact person
1st name Masaya
Middle name
Last name Sakamoto
Organization ikei University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code 105-8461
Address 3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Homepage URL
Email m-sakamoto@umin.ac.jp

Sponsor
Institute Jikei University School of Medicine
Institute
Department

Funding Source
Organization Jikei University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Jikei University School of Medicine
Address 3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
Tel 03-3433-1111
Email m-sakamoto@umin.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 東京慈恵会医科大学附属病院

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 02 Day

Related information
URL releasing protocol This study showed that short-term GV was correlated with short-term BPV.
Publication of results Unpublished

Result
URL related to results and publications english maniscript journal
Number of participants that the trial has enrolled 41
Results 
This study showed that short-term GV was correlated with short-term BPV. Our findings may help to explain the increased cardiovascular risk in patients with T2DM.
Results date posted
2019 Year 05 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
We retrospectively evaluated the relationship between short-term GV and BPV at the same time in individual T2DM patients receiving diet and/or anti-diabetic treatment for hospital inpatient. Short-term GV (24-hour) was assessed by measuring coefficient of variation (CV) and the mean amplitude of glycemic excursions (MAGE) during continuous glucose monitoring. Ambulatory blood pressure monitoring data were used to evaluate the short-term BPV (systolic and diastolic) including CV of 24-hour, daytime, and nighttime.
Participant flow 
retrospettive
Adverse events 
none
Outcome measures 
Tke relationship between short-term glucose variability and short-term blood pressure variability
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 01 Month 01 Day
Date of IRB
2017 Year 12 Month 30 Day
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We retrospectively evaluated the relationship between short-term GV and BPV at the same time in individual T2DM patients receiving diet and/or anti-diabetic treatment for hospital inpatient. Short-term GV (24-hour) was assessed by measuring coefficient of variation (CV) and the mean amplitude of glycemic excursions (MAGE) during continuous glucose monitoring. Ambulatory blood pressure monitoring data were used to evaluate the short-term BPV (systolic and diastolic) including CV of 24-hour, daytime, and nighttime.

Management information
Registered date
2019 Year 05 Month 02 Day
Last modified on
2019 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041739