UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034231 |
|---|---|
| Receipt number | R000039019 |
| Scientific Title | Seasonal variations in the achievement of guideline targets for HbA1c, blood pressure, and cholesterol among type 2 diabetic patients: A nationwide population-based study |
| Date of disclosure of the study information | 2018/09/21 |
| Last modified on | 2018/09/21 17:09:51 |
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Basic information
Public title
Seasonal variations in the achievement of guideline targets for HbA1c, blood pressure, and cholesterol among type 2 diabetic patients: A nationwide population-based study
Acronym
ABC study
Scientific Title
Seasonal variations in the achievement of guideline targets for HbA1c, blood pressure, and cholesterol among type 2 diabetic patients: A nationwide population-based study
Scientific Title:Acronym
ABC study
Region
| Japan |
Condition
Condition
Type 2 diabetic Patient
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The monthly achievement rates for each value that are required to determine the specific treatment strategy remains unknown.we evaluate, rates of achievement of guideline targets for HbA1c, BP, and low-density lipoprotein (LDL)-cholesterol on a monthly basis in patients with T2DM and explored factors affecting the achievement rates.
Basic objectives2
Others
Basic objectives -Others
Find factors related to HbA1c variability.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary objective was to evaluate the all ABC (HbA1c,Blood pressure,LDL-C) achievement rate for each month.
2 years from 2013 to 2014
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
The inclusion criteria were patients whose HbA1c,BP,and LDL-cholesterol were measured 12 or more times during the two-year period between January 2013 and December2014; who were age greater than or equal to 20 years and under 75 years; and who had T2DM diagnosed based on criteria in the Report of the Committee of Japan Diabetes Society on the Classification and Diagnostic Criteria of Diabetes Mellitus.
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
5000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | masaya sakamoto |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
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 | |
| Middle name | |
| Last name | Masaya Sakamoto |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
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
Address
Tel
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
| 2018 | Year | 09 | Month | 21 | 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
Main results already published
Date of protocol fixation
| 2017 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
Of the 104,601 registered patients in 38 medical clinics, 4,678 were finally included in the analysis.
Management information
Registered date
| 2018 | Year | 09 | Month | 21 | Day |
Last modified on
| 2018 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039019
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
