UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033282 |
|---|---|
| Receipt number | R000037943 |
| Scientific Title | A multicenter cohort study to identify factors associated with barriers to and determinants of poor glycemic control and periodontal disease among type 2 diabetic patients in Bangladesh. |
| Date of disclosure of the study information | 2018/07/04 |
| Last modified on | 2022/07/15 22:44:00 |
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Basic information
Public title
A multicenter cohort study to identify factors associated with barriers to and determinants of poor glycemic control and periodontal disease among type 2 diabetic patients in Bangladesh.
Acronym
A multicenter cohort study to examine determinants of poor glycemic control and periodontal disease among type 2 diabetic patients in Bangladesh.
Scientific Title
A multicenter cohort study to identify factors associated with barriers to and determinants of poor glycemic control and periodontal disease among type 2 diabetic patients in Bangladesh.
Scientific Title:Acronym
A multicenter cohort study to examine determinants of poor glycemic control and periodontal disease among type 2 diabetic patients in Bangladesh.
Region
| Asia(except Japan) |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the factors associated with glycemic control and priodontal disease among type 2 diabetics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c, 6 months later
Key secondary outcomes
BMI, 6 month later
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
| 21 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Receiving treatment at diabetes centers at Dahka, Rajshahi, or Barisal, for at least 12 months.
Agree to participate in the study.
Prescribed anti-diabetes medicine at least once between July 1, 2018 and August 31, 2018
Key exclusion criteria
Prescribed insulin for injection
Diagnosed as polycystic ovarian syndrome or overt diabetes in pregnancy
Participant in other clinical trials
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Nakamura |
Organization
Tokyo Medical and Dental University
Division name
Department of Global Health Entrepreneurship
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-4048
nakamura.ith@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Keiko Nakamura |
Organization
Tokyo Medical and Dental University
Division name
Department of Global Health Entrepreneurship
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-4048
Homepage URL
nakamura.ith@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Tokyo Medical and Dental University Medical School
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel
+81-3-5803-5096
syomu1.adm@tmd.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 04 | 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
500
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
| 2018 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Follow up diabetes patients for 6 months and analyze relationship between good control of HbA1c, BMI and periodontal disease, lifestyles, knowledge about diabetes and socioeconomic conditions.
Management information
Registered date
| 2018 | Year | 07 | Month | 04 | Day |
Last modified on
| 2022 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037943
| Research Plan | |
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| 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 |
