UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041065 |
|---|---|
| Receipt number | R000046901 |
| Scientific Title | A survey on the lifestyle changes of patients with diabetes under the state of emergency |
| Date of disclosure of the study information | 2020/07/10 |
| Last modified on | 2021/05/10 10:45:00 |
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Basic information
Public title
A survey on the lifestyle changes of patients with diabetes under the state of emergency
Acronym
A survey on the lifestyle changes of patients with diabetes under the state of emergency
Scientific Title
A survey on the lifestyle changes of patients with diabetes under the state of emergency
Scientific Title:Acronym
A survey on the lifestyle changes of patients with diabetes under the state of emergency
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the management status of the blood sugar level and weight of the patients with diabetes under the state of emergency due to the COVID-19 epidemic.
Basic objectives2
Others
Basic objectives -Others
epidemiologic study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c before and after the state of emergency
Key secondary outcomes
Change in weight before and after the state of emergency.
Each answer to the questionnaire.
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
The survey targets are those who meet all of the following criteria;
1. Patients who visit "Berry Clinic" or "Tomonaga Clinic" regularly.
2. Any patients regardless of their gender and age
3. Patients with diabetes.
4. Patients who consent to participate in the survey.
Key exclusion criteria
N/A
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Mio |
| Middle name | |
| Last name | Masuda |
Organization
Berry Clinic
Division name
N/A
Zip code
272-0143
Address
Cradea M&S 1F, 4-14-10 Ainokawa, Ichikawa City, Chiba
TEL
047-358-6318
berryclinic@icloud.com
Public contact
Name of contact person
| 1st name | Mio |
| Middle name | |
| Last name | Masuda |
Organization
Berry Clinic
Division name
N/A
Zip code
272-0143
Address
Cradea M&S 1F, 4-14-10 Ainokawa, Ichikawa City, Chiba
TEL
047-358-6318
Homepage URL
berryclinic@icloud.com
Sponsor or person
Institute
Berry Clinic
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Diabetes and lifestyle Center, Tomonaga Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee at the Diabetes and lifestyle Center, Tomonaga Clinic
Address
Shinyon curumu building 9F, 4-2-23, Shinjuku, Shinjuku-ku, Tokyo, Japan
Tel
03-3351-0032
info@tomonaga-clinic.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
ベリークリニック/Berry Clinic、ともながクリニック 糖尿病・生活習慣病センター/The Diabetes and lifestyle Center, Tomonaga Clinic
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s13340-021-00505-6
Number of participants that the trial has enrolled
1000
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 04 | Month | 20 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 23 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 28 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 13 | Day |
Date analysis concluded
| 2020 | Year | 11 | Month | 30 | Day |
Other
Other related information
Observational Study
Management information
Registered date
| 2020 | Year | 07 | Month | 10 | Day |
Last modified on
| 2021 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046901
| 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 |
