UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043571 |
|---|---|
| Receipt number | R000049760 |
| Scientific Title | Development of a remote guidance system and demonstration of improvement for obesity and fatty liver using ICT |
| Date of disclosure of the study information | 2021/03/09 |
| Last modified on | 2021/03/09 22:46:37 |
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Basic information
Public title
Development of a remote guidance system and demonstration of improvement for obesity and fatty liver using ICT
Acronym
Saku Remote Project (SakuRemo)
Scientific Title
Development of a remote guidance system and demonstration of improvement for obesity and fatty liver using ICT
Scientific Title:Acronym
Saku Remote Project (SakuRemo)
Region
| Japan |
Condition
Condition
Obesity, fatty liver, prediabetes
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether remote nutritional guidance interventions using ICT-based PHR applications and FGM can improve obesity and fatty liver as much as conventional methods without monthly face-to-face outpatient guidance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight change after 6 months (weight loss of at least 7.0%)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Remote nutritional guidance using ICT-based PHR application and FGM
Interventions/Control_2
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who have been diagnosed with obesity
2) written informed consent
Key exclusion criteria
1) Patients who have been diagnosed with diabetes mellitus
2) Patients with a recent eGFR <30 ml/min/1.73m2
3) Patients with drug addiction
4) Patients with carcinoma
5) Patients who have had a myocardial infarction within the past 6 months
6) Patients with severe heart failure of New York Heart Association (NYHA) grade 3 or higher
7) Patients with learning disabilities
8) Patients being treated with anti-obesity drugs
(9) Patients diagnosed with eating disorders
10) Pregnant women, lactating women, and patients with the possibility (intention) of pregnancy
11) Patients with depression requiring inpatient treatment or patients taking antipsychotic medication
(12) Patients who are participating in other clinical research
(13) Other patients who are judged by the medical doctor to be unsuitable for the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Ogata |
Organization
Asama General Hospital
Division name
Surgery
Zip code
385-8558
Address
1862-1 Iwamurada, Saku, Nagano
TEL
0267-67-2295
ogatas0520@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | Ito |
Organization
Chuo University
Division name
Research and Development Initiative Laboratory of Lifestyle-related Disease Prevention System
Zip code
112-8551
Address
1-3-27 Kasuga, Bunkyou, Tokyo
TEL
03-3817-7280
Homepage URL
http://c-faculty.chuo-u.ac.jp/~healthy/saku-remote/
mariito.18x@g.chuo-u.ac.jp
Sponsor or person
Institute
Institute of Nonalcoholic Steatohepatitis Japan
Institute
Department
Personal name
Funding Source
Organization
Institute of Nonalcoholic Steatohepatitis Japan
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
Asama General Hospital
Address
1862-1 Iwamurada, Saku, Nagano
Tel
0267-67-2295
asama-soumu@city.saku.nagano.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 09 | 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
| 2020 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 09 | 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
| 2021 | Year | 03 | Month | 09 | Day |
Last modified on
| 2021 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049760
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
