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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032163
Receipt No. R000036512
Scientific Title Analysis of body composition change of diabetic patients by aggressive exercise therapy for 3 months
Date of disclosure of the study information 2018/04/11
Last modified on 2019/04/10

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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
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 Enrolling by invitation
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
2023 Year 03 Month 31 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
2019 Year 04 Month 10 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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