UMIN-CTR Clinical Trial

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
Email	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/
Email	mariito.18x@g.chuo-u.ac.jp

Sponsor
Institute	Institute of Nonalcoholic Steatohepatitis Japan
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049760