UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044851 |
|---|---|
| Receipt number | R000050532 |
| Scientific Title | Comprehensive analysis of the effects of the SARS-CoV-2 epidemic on the treatment, blood, urine and physical data of diabetic patients and dietary habits |
| Date of disclosure of the study information | 2021/07/13 |
| Last modified on | 2024/01/14 11:52:42 |
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Basic information
Public title
Comprehensive analysis of the effects of the COVID-19 epidemic on the treatment, blood, urine and physical data of diabetic patients and dietary habits
Acronym
Comprehensive analysis of the effects of the COVID-19 epidemic on the treatment, blood, urine and physical data of diabetic patients and dietary habits
Scientific Title
Comprehensive analysis of the effects of the SARS-CoV-2 epidemic on the treatment, blood, urine and physical data of diabetic patients and dietary habits
Scientific Title:Acronym
Comprehensive analysis of the effects of the SARS-CoV-2 epidemic on the treatment, blood, urine and physical data of diabetic patients and dietary habits
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the relationship between lifestyle changes caused by the pandemic and diabetes treatment.
Basic objectives2
Others
Basic objectives -Others
To analyze the effect of lifestyle changes due to SARS-CoV-2 pandemic on diabetes mellitus.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood test data
Urinalysis data
Physical measurements
Lifestyle habits
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who visited the University of Tokyo Hospital as outpatients from January 2019 to March 2021 and for whom medication was administered for diabetes treatment, and all patients with diabetic type by blood sampling
Key exclusion criteria
Those who have applied to opt out
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Kubota |
Organization
The University of Tokyo Hospital
Division name
Department of Clinical Nutrition Therapy
Zip code
113-8655
Address
7-3-1,Hongou,Bunkyoku,Tokyo,Japan
TEL
03-3815-5411
nkubota-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Okuma |
Organization
The University of Tokyo
Division name
Department of Diabetes and Metabolic Diseases
Zip code
113-8655
Address
7-3-1,Hongou,Bunkyoku,Tokyo,Japan
TEL
03-3815-5411
Homepage URL
okumak-int@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
No
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 University of Tokyo
Address
7-3-1, Hongou,Bunkyoku,Tokyo,Tapan
Tel
0338155411
okumak-int@h.u-tokyo.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
| 2021 | Year | 07 | Month | 13 | 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
10000
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
| 2021 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 27 | Day |
Date of closure to data entry
| 2026 | Year | 06 | Month | 27 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Perform analysis using physical and laboratory data.
Management information
Registered date
| 2021 | Year | 07 | Month | 13 | Day |
Last modified on
| 2024 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050532
| 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 |
