UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032163 |
|---|---|
| Receipt number | 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 | 2020/03/17 15:22:44 |
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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
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
yskhrt-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036512
