UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043008
Receipt number R000045973
Scientific Title Association between physical activity and glycemic control in type 1 diabetes
Date of disclosure of the study information 2021/01/15
Last modified on 2024/01/22 15:57:18

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Basic information

Public title

Association between physical activity and glycemic control in type 1 diabetes

Acronym

Association between physical activity and glycemic control in type 1 diabetes

Scientific Title

Association between physical activity and glycemic control in type 1 diabetes

Scientific Title:Acronym

Association between physical activity and glycemic control in type 1 diabetes

Region

Japan


Condition

Condition

Type 1 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the association between physical activity and glycemic control in people with type 1 diabetes (cross-sectional and longitudinal study).

Basic objectives2

Others

Basic objectives -Others

To manage clinical condition in people with type 1 diabetes

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Term for evaluation
At baseline, at 1 year

Evaluation items
Glycemic control (HbA1c)

Key secondary outcomes

Term for evaluation
At baseline, at 1 year

Evaluation items
1. glycoalbumin (GA), blood glucose fluctuation
2. Blood lipids profile, body weight, body fat mass, waist circumference, blood pressure
3. Physical activity


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

20 years-old <=

Age-upper limit

74 years-old >=

Gender

Male and Female

Key inclusion criteria

Outpatients with type 1 diabetes

Key exclusion criteria

1. Patients who have been diagnosed with diabetes for less than a year
2. Patients whose daily physical activities restricted by cardiovascular or motor dysfunction
3. Patients with severe chronic complications of diabetes.
4. Patients with cognitive decline

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Hiroto
Middle name
Last name Honda

Organization

Shijonawate Gakuen University

Division name

Faculty of Rehabilitation

Zip code

574-0011

Address

5-11-10 Hojo, Daito, Osaka

TEL

072-863-5043

Email

h-honda@un.shijonawate-gakuen.ac.jp


Public contact

Name of contact person

1st name Hiroto
Middle name
Last name Honda

Organization

Shijonawate Gakuen University

Division name

Faculty of Rehabilitation

Zip code

574-0011

Address

5-11-10 Hojo, Daito, Osaka

TEL

072-863-5043

Homepage URL


Email

h-honda@un.shijonawate-gakuen.ac.jp


Sponsor or person

Institute

Shijonawate Gakuen University

Institute

Department

Personal name



Funding Source

Organization

Japan Association for Diabetes Education and Care

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shijonawate Gakuen University

Address

5-11-10 Hojo, Daito, Osaka

Tel

072-863-5043

Email

k-hanada@un.shijonawate-gakuen.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

神戸大学医学部附属病院(兵庫県)、兵庫県立姫路循環器病センター(兵庫県)、淀川キリスト教病院(大阪府)、神鋼記念病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2021 Year 01 Month 15 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

126

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

Completed

Date of protocol fixation

2018 Year 03 Month 22 Day

Date of IRB

2018 Year 04 Month 03 Day

Anticipated trial start date

2018 Year 12 Month 03 Day

Last follow-up date

2021 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The purpose of this study is to evaluate the association between physical activity and glycemic control in people with type 1 diabetes (cross-sectional and longitudinal study)


Management information

Registered date

2021 Year 01 Month 15 Day

Last modified on

2024 Year 01 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045973


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name