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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000037553 |
Receipt No. | R000042817 |
Scientific Title | Development of prevention program using community based participatory approach to seasonal variation of HbA1c levels in patients with diabetes mellitus |
Date of disclosure of the study information | 2019/07/31 |
Last modified on | 2019/07/31 |
Basic information | ||
Public title | Development of prevention program using community based participatory approach to seasonal variation of HbA1c levels in patients with diabetes mellitus | |
Acronym | Development of prevention program using community based participatory approach to seasonal variation of HbA1c levels in patients with diabetes mellitus | |
Scientific Title | Development of prevention program using community based participatory approach to seasonal variation of HbA1c levels in patients with diabetes mellitus | |
Scientific Title:Acronym | Development of prevention program using community based participatory approach to seasonal variation of HbA1c levels in patients with diabetes mellitus | |
Region |
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Condition | ||
Condition | diabetes mellitus | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | 1. To confirm the seasonal variation of HbA1c levels in patients with diabetes mellitus in a retrospective cohort and confirm whether the seasonal variation of HbA1c is related to social determinants of health.
2. Intervention of prevention program using community based participatory approach to seasonal variation of HbA1c, confirm seasonal variation of HbA1c. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | HbA1c, cardiovascular disease, survival. |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Single blind -investigator(s) and assessor(s) are blinded |
Control | No treatment |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Nutrition therapy | |
Interventions/Control_2 | No nutrition therapy | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | patients with diabetes mellitus | |||
Key exclusion criteria | Cases without type 2 diabetes.
4 or more stage diabetic nephropathy or renal failure case equivalent to it. Steroid treatment, case during chemotherapy |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Iwate Medical University | ||||||
Division name | General medical department | ||||||
Zip code | 0208505 | ||||||
Address | 19-1 Uchimaru Morioka city Iwate | ||||||
TEL | 0196515111 | ||||||
daiki.k.0723@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Iwate Medical University | ||||||
Division name | General medical department | ||||||
Zip code | 0208505 | ||||||
Address | 19-1 Uchimaru Morioka city Iwate | ||||||
TEL | 0196515111 | ||||||
Homepage URL | |||||||
daiki.k.0723@gmail.com |
Sponsor | |
Institute | Iwate Medical University |
Institute | |
Department |
Funding Source | |
Organization | None |
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 | Iwate Medical University |
Address | 19-1 Uchimaru Morioka city Iwate |
Tel | 0196515111 |
daiki.k.0723@gmail.com |
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 |
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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 | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042817 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |