UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036639 |
|---|---|
| Receipt number | 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 15:56:09 |
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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
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
m-sakamoto@umin.ac.jp
Public contact
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
m-sakamoto@umin.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041739
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