UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of body composition change of diabetic patients by aggressive exercise therapy for 3 months
Acronym	Analysis of body composition change of diabetic patients by aggressive exercise therapy for 3 months
Scientific Title	Analysis of body composition change of diabetic patients by aggressive exercise therapy for 3 months
Scientific Title:Acronym	Analysis of body composition change of diabetic patients by aggressive exercise therapy for 3 months
Region	Japan

Condition
Condition	Type 2 diabetes, obesity, metabolic syndrome
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To conduct exercise therapy intervention and support by telemedicine system for outpatient for 3 months to check whether desirable change in body composition can be obtained. To Confirm whether expected change in body composition can be obtained by exercise therapy intervention and support by telemedicine. To search for the relationship between genetic information from blood specimens and urine samples and clinical data and therapeutic effects, some analyses are planned: single nucleotide polymorphism (SNP) analysis and metabolome analysis of candidate genes that are suggested to be related to body composition etc. .
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change rate of visceral fat area
Key secondary outcomes	Skeletal muscle mass, skeletal muscle ratio, HbA1c, body weight, body fat percentage, subcutaneous fat area, change rate of subcutaneous fat area, grip strength, walking speed, fasting blood sugar, fasting insulin, change in self management (questionnaire), Locomo 25 (questionnaire), dietary habit (questionnaire)

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Behavior,custom
Interventions/Control_1	Active exercise therapy
Interventions/Control_2	Remote self-management system
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	40 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who satisfy all the following criteria are targeted. 1) Type 2 diabetes 2) At the time of participation Patients over 40 years old and under 75 years old 3) Patients with BMI 22 kg/m^2 or more and less than 35 kg/m^2 4) Low daily activity, or normal patient 5) Patients who were negative in screening treadmill test 6) Patient who understands the system of self administration support system DialBetics and can use it appropriately 7) Patient who agreed with written consent by his / her free will after understanding with sufficient explanation
Key exclusion criteria	Patients applicable to even one of the following are not included. 1) Those considered to be inappropriate for exercise therapy due to the progress of complications of diabetes (retinopathy: pre-proliferative retinopathy / proliferative retinopathy patients, nephropathy: CKD stage G3b or more, Patients with neuropathy: autonomic nervous disorder, orthostatic hypotension, disappearance of respiratory arrhythmia, and resting tachycardia clearly recognized) 2) Patients with a history of macroangiopathy 3) Patients who violate absolute contraindications or relative contraindications of treadmill examinations(According to guidelines on rehabilitation in cardiovascular disease (2012 revised edition)). Patients who were positive for treadmill examination 4) Users using implantable medical electrical equipment such as pacemakers 5) Female patient during pregnancy, lactating 6) Patients scheduled for surgery within 6 months 7) Patients suffering from malignant tumors 8) Patients whose body composition is extremely biased, patients who may interfere with accurate measurement of body composition 9) Patients who do not satisfy the measurement objectives recommended for body composition measuring instruments 10) Patients with obvious dementia 11) Patients with mental illness 12) Patients who have orthopedic disease and difficult exercise therapy 13) Patients whose visit to our hospital outpatient is irregular 14) Patients participating in other clinical research and clinical trials 15) Patients judged inappropriate as subjects by this research director
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kayo Waki
Organization	School of Medicine, The University of Tokyo
Division name	Department of Ubiquitous Health Informatics
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-5800-9129
Email	uhi-office@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yusuke Hirota
Organization	School of Medicine, The University of Tokyo
Division name	Department of Diabetes and Metabolic Diseases
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	yskhrt-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	The University of Tokyo
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	2018 Year 04 Month 11 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	13
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	Terminated
Date of protocol fixation	2018 Year 08 Month 30 Day
Date of IRB	2018 Year 08 Month 30 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2019 Year 11 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 09 Day
Last modified on	2020 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036512