UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045490 |
|---|---|
| Receipt number | R000051935 |
| Scientific Title | Body composition of obese patients before and after metabolic surgery using advanced ICT systems (randomized controlled trial) |
| Date of disclosure of the study information | 2021/10/21 |
| Last modified on | 2025/03/18 13:23:28 |
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Basic information
Public title
Body composition of obese patients before and after metabolic surgery using advanced Information and Communication Technology (ICT) systems (randomized controlled trial)
Acronym
Body composition of obese patients using ICT systems
Scientific Title
Body composition of obese patients before and after metabolic surgery using advanced ICT systems (randomized controlled trial)
Scientific Title:Acronym
Body composition of obese patients using ICT systems
Region
| Japan |
Condition
Condition
Obesity, Metabolic syndrome
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of nutrition and exercise intervention guidance using an advanced ICT system for obese patients before and after metabolic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in postperative excess weight loss (%EWL) with and without intervention guidance.
Key secondary outcomes
Comparison of diabetes remission and metabolic parameters in ICT systems intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Uses a body composition monitor (Aria2), handheld device (Fitbit), and smartphone app for 9 months, 24hours a day, 7days a week.
Interventions/Control_2
Uses no body composition monitor, handheld device, or smartphone app.
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
Obese adult patients between the ages of 20 and 75 who are currently attending the University of the Ryukyus Hospital and who are considering metabolic surgery, and have access to the health management apps and devices.
Key exclusion criteria
Patients who are assessed by the attending physician to be inappropriate for the study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Masuzaki |
Organization
Graduate School of Medicine, University of the Ryukyus.
Division name
Division of Endocrinology, Diabetes and Metabolism,Hematology, Rheumatology.
Zip code
903-0215
Address
207 Uehara, Nishihara, Okinawa,903-0215,Japan
TEL
098-895-1146
hiroaki@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Tsugumi |
| Middle name | |
| Last name | Uema |
Organization
Graduate School of Medicine, University of the Ryukyus.
Division name
Division of Endocrinology, Diabetes and Metabolism,Hematology, Rheumatology.
Zip code
903-0215
Address
207 Uehara, Nishihara, Okinawa,903-0215,Japan
TEL
098-895-1146
Homepage URL
ma2.ky8.26@gmail.com
Sponsor or person
Institute
University of the Ryukyus.
Institute
Department
Personal name
Funding Source
Organization
Division of Endocrinology, Diabetes and Metabolism,Hematology, Rheumatology.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
H.U. Group Research Institute
IRB Contact (For public release)
Organization
University of the Ryukyus.
Address
207 Uehara, Nishihara, Okinawa,903-0215,Japan
Tel
098-895-1542
krinken@acs.u-ryukyu.ac.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 | 10 | Month | 21 | 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
6
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
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 15 | Day |
Last modified on
| 2025 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051935
