UMIN-CTR Clinical Trial

Basic information
Public title	A study on the usefulness of exercise and home blood pressure in diabetic patients
Acronym	Effect of exercise on home blood pressure in diabetic patients
Scientific Title	A study on the usefulness of exercise and home blood pressure in diabetic patients
Scientific Title:Acronym	Effect of exercise on home blood pressure in diabetic patients
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we will examine the superiority of randomized comparison between exercise therapy lead group and exercise therapy lag group for diabetic patients who undergo outpatient visit treatment, for the utility of exercise therapy for domestic blood pressure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The main endpoint is the average value of nocturnal blood pressure from 24 to 28 days after exercise therapy compared with when exercise therapy is not performed.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	During exercise therapy, we instruct the patient to conduct exercise therapy more than 3 days a week, 30 minutes walk twice a day or 60 minutes walk once a day for 2 weeks as guidance of exercise therapy.
Interventions/Control_2	While exercise therapy is not performed, we instruct the patient not to do any exercise therapy during the research period.
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Selection criteria are that diagnosis of diabetes is obtained based on diagnostic criteria of Japanese Diabetes Society, that it is a case of 20 years old or younger than 90 years old, and that the patient consent was obtained from the patient himself before registration in the study.
Key exclusion criteria	Patients whose urine ketone bodies are more moderate or more positive, have kidney dysfunction, or undergoing hemodialysis treatment. Patients with advanced diabetic autonomic neuropathy, or fresh bleeding due to proliferative retinopathy. Patients with serious liver disease or endocrine disorder. Patients with heart lung disease, cerebrovascular disease and orthopedic disease that are difficult to exercise. Patients who are considered inappropriate for participation by responsible researcher or attending physician for other safety reasons.
Target sample size	110

Research contact person
Name of lead principal investigator	1st name Michiaki Middle name Last name Fukui
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Endocrinology and Metabolism
Zip code	602-8566
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	+81-75-251-5505
Email	michiaki@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Keiko Middle name Last name Iwai
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Endocrinology and Metabolism
Zip code	602-8566
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5506
Homepage URL	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040969
Email	keiko816@koto.kpu-m.ac.jp

Sponsor
Institute	Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Administration grant (classroom fee)
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Keiko Iwai
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
Tel	075-251-5506
Email	keiko816@koto.kpu-m.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	京都府立医科大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 06 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
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	2019 Year 02 Month 13 Day
Date of IRB	2019 Year 02 Month 22 Day
Anticipated trial start date	2019 Year 03 Month 20 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 07 Month 03 Day
Date trial data considered complete	2020 Year 07 Month 03 Day
Date analysis concluded	2021 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date	2019 Year 02 Month 22 Day
Last modified on	2021 Year 02 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040969