UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047833 |
|---|---|
| Receipt number | R000054530 |
| Scientific Title | A retrospective study investigating the effects of lifestyle-related changes on glycemic changes in patients with type 2 diabetes before and after the epidemic of new coronavirus infection |
| Date of disclosure of the study information | 2022/05/23 |
| Last modified on | 2022/05/23 14:31:50 |
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Basic information
Public title
A retrospective study investigating the effects of the epidemic of new coronavirus infection on lifestyle-related changes in patients with type 2 diabetes
Acronym
A retrospective study investigating the effects of the epidemic of new coronavirus infection on lifestyle-related changes in patients with type 2 diabetes
Scientific Title
A retrospective study investigating the effects of lifestyle-related changes on glycemic changes in patients with type 2 diabetes before and after the epidemic of new coronavirus infection
Scientific Title:Acronym
A retrospective study investigating the effects of lifestyle-related changes on glycemic changes in patients with type 2 diabetes before and after the epidemic of new coronavirus infection
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate whether there is a difference in HbA1c before and after the epidemic of COVID-19 in type 2 diabetic patients.
Basic objectives2
Others
Basic objectives -Others
We will also evaluate changes in lifestyle habits, including exercise habits.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in HbA1c before and after the epidemic of COVID-19
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Target patients who meet all of the following criteria.
1) Patients with type 2 diabetes who continue to visit our hospital
2) Patients whose necessary data collection items (described later) are all recorded on the electronic medical record
Key exclusion criteria
Patients who cannot collect necessary data items in the medical record
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kensaku |
| Middle name | |
| Last name | Fukunaga |
Organization
Kagawa University Hospital
Division name
endocrinology metabolism
Zip code
761-0793
Address
1750-1,Miki-cho, Kita-gun
TEL
0878912230
fukunaga.kensaku@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kensaku |
| Middle name | |
| Last name | Fukunaga |
Organization
Kagawa University Hospital
Division name
endocrinology metabolism
Zip code
761-0793
Address
1750-1,Miki-cho, Kita-gun
TEL
0878912230
Homepage URL
fukunaga.kensaku@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kagawa University Hospital
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 Ethics Committee, faculty of medicine, kagawa university
Address
1750-1,Miki-cho, Kita-gun
Tel
0878912230
fukunaga.kensaku@kagawa-u.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
| 2022 | Year | 05 | Month | 23 | Day |
Related information
URL releasing protocol
https://www.anncaserep.com/open-access/impact-of-covid19-pandemic-on-glycemic-control-eating-behavio
Publication of results
Published
Result
URL related to results and publications
https://www.anncaserep.com/open-access/impact-of-covid19-pandemic-on-glycemic-control-eating-behavio
Number of participants that the trial has enrolled
200
Results
Two hundred participants completed the survey. During the COVID-19 pandemic, the average HbA1c values significantly deteriorated (7.72%) than those pre-pandemics (7.57%), with an increase of 1.98 percent (p=0.002, r= -0.157). Additionally, the scores for All Physical Activities (all PA) decreased and total eating behaviors improved. There was no significant relationship was found between the HbA1 values, physical activities, and eating behaviors during the pandemic.
Results date posted
| 2022 | Year | 05 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 02 | Month | 16 | Day |
Baseline Characteristics
T2D patients
Participant flow
Study involved both retrospective and cross-sectional data analyses. The glycated Hemoglobin (HbA1c) values in patients with type 2 diabetes before the pandemic in 2019 and during pandemic in 2020 were evaluated. A self-administered questionnaire survey was used to measure physical activity and eating behaviors. Patients with type 2 diabetes who had HbA1c values > 7% at any month during 2020 were included. Data collection was performed at the medical outpatient clinic of Kagawa University Hospital.
Adverse events
None
Outcome measures
Changes in HbA1c before and after the epidemic of COVID-19
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Outbreak of COVID-19 infection among type 2 diabetic patients who are visiting our hospital and who visited our hospital between January 1, 2019 and December 31, 2020. Evaluate whether there is a difference in HbA1c before and after.
Management information
Registered date
| 2022 | Year | 05 | Month | 23 | Day |
Last modified on
| 2022 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054530
