UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028904
Receipt No. R000033080
Scientific Title Exercise education using data management sysytem and Mediwalk in patients with type 2 diabetes mallitus
Date of disclosure of the study information 2017/08/30
Last modified on 2019/01/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Exercise education using data management sysytem and Mediwalk in patients with type 2 diabetes mallitus
Acronym Mediwalk for patients with type 2 diabetes
Scientific Title Exercise education using data management sysytem and Mediwalk in patients with type 2 diabetes mallitus
Scientific Title:Acronym Mediwalk for patients with type 2 diabetes
Region
Japan

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

Objectives
Narrative objectives1 To examne the efficacy of exercise education for patients with type diabetes mellitus using data management system and Mediwalk
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c
Key secondary outcomes body composition
blood pressure, lipid profile, hsCRP, adiponectin, renal function
questionnaire about exercise

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Exercise education using Mediwalk with data management system every month for 6 months
Interventions/Control_2 Exercise education using Mediwalk without data management system every month for 6 months
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

Not applicable
Gender Male and Female
Key inclusion criteria patients with type 2 diabetes
HbA1c 7.0% and over
Key exclusion criteria patients who cannot play exercise
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihiko Yanase
Organization Fukuoka university, school of medicine
Division name Endocrinology and diabetes mellitus
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL 092-801-1011
Email tyanase@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Nomiyama
Organization Fukuoka university, school of medicine
Division name Endocrinology and diabetes mellitus
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL 092-801-1011
Homepage URL
Email tnomiyama@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka university, school of medicine
Institute
Department

Funding Source
Organization Fukuoka university, school of medicine
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
Address
Tel
Email

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
2017 Year 08 Month 30 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 Completed
Date of protocol fixation
2016 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 06 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 30 Day
Last modified on
2019 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033080

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.