UMIN-CTR Clinical Trial

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
Email	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
Email	fukunaga.kensaku@kagawa-u.ac.jp

Sponsor
Institute	Kagawa University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054530