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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033282
Receipt No. 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 2019/07/17

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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
Email 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
Email nakamura.ith@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Email 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 No longer recruiting
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
2019 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037943

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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