UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037179 |
|---|---|
| Receipt number | R000042371 |
| Scientific Title | Contributing factors associated with visit-to-visit variability of HbA1c and blood pressure in type 2 diabetic patients: a real world analysis (JDDM) |
| Date of disclosure of the study information | 2019/06/27 |
| Last modified on | 2019/06/26 16:01:56 |
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Basic information
Public title
Contributing factors associated with visit-to-visit variability of HbA1c and blood pressure in type 2 diabetic patients: a real world analysis (JDDM)
Acronym
Contributing factors associated with visit-to-visit variability of HbA1c and blood pressure in type 2 diabetic patients: a real world analysis (JDDM)
Scientific Title
Contributing factors associated with visit-to-visit variability of HbA1c and blood pressure in type 2 diabetic patients: a real world analysis (JDDM)
Scientific Title:Acronym
Contributing factors associated with visit-to-visit variability of HbA1c and blood pressure in type 2 diabetic patients: a real world analysis (JDDM)
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary study objective was evaluation of contributing factors of VVV of HbA1c and SBP.
Basic objectives2
Others
Basic objectives -Others
Secondary objectives included the evaluation of monthly mean HbA1c for each mean HbA1c groups; multiple comparison of median VVV of HbA1c among the mean HbA1c groups; monthly SBP for each mean SBP groups; and multiple comparison of median VVV of SBP among the mean SBP groups.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary study objective was evaluation of contributing factors of VVV of HbA1c and SBP.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
This study analyzed data from ABC trial (Diabetes Care. 2019) in order to explore contributing factors that increase VVV of HbA1c and BP. The ABC trial initially analyzed data on 104,601 persons. In this study, a total of 15,927 patients with T2DM whose HbA1c and BP were measured more than 12 times during the two years (January 2013 to December 2014) were enrolled.
Key exclusion criteria
Exclusion criteria were not visiting the clinic regularly, visit intervals ofgreater than or equal to 2 months; type 1 diabetes mellitus; hemodialysis for end-stage renal failure; and information not available on anti-diabetic drugs, anti-hypertensive agents, lipid-lowering agents, antiplatelet drug use, current smoking status, alcohol drinking status, family history of diabetes, or diabetes duration
Target sample size
17000
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Sakamoto |
Organization
The Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
105-8471
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
m-sakamoto@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Sakamoto |
Organization
The Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
105-8471
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
Homepage URL
m-sakamoto@umin.ac.jp
Sponsor or person
Institute
Japan Diabetes Clinical Data Management (JDDM)
Institute
Department
Personal name
Funding Source
Organization
Tsuruoka Kyoritsu Hospital
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
The Jikei University School of Medicine
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo, Japan
Tel
03-3433-1111
m-sakamoto@umin.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
JDDM2017-6
Org. issuing International ID_1
Japan Diabetes Clinical Data Management (JDDM)
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 | 06 | Month | 27 | 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
17000
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 06 | Month | 26 | Day |
Last modified on
| 2019 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042371
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| Registered date | File name |
| Research case data | |
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