UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061562 |
|---|---|
| Receipt number | R000070439 |
| Scientific Title | A prospective observational study of changes in quality of life and work productivity in individuals undergoing metabolic and bariatric surgery |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/05/13 23:19:33 |
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Basic information
Public title
A prospective observational study of changes in quality of life and work productivity in individuals undergoing Metabolic and Bariatric Surgery
Acronym
Metabolic and Bariatric Surgery PRO Study
Scientific Title
A prospective observational study of changes in quality of life and work productivity in individuals undergoing metabolic and bariatric surgery
Scientific Title:Acronym
MBS-PRO Study
Region
| Japan |
Condition
Condition
Obesity disease
Classification by specialty
| Endocrinology and Metabolism | Endocrine surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to evaluate the change in the IWQOL-Lite-CT physical function composite score from baseline to 72 weeks after metabolic and bariatric surgery in patients with obesity disease who are scheduled to undergo metabolic and bariatric surgery under routine insured clinical care at Kobe University Hospital or Chibune Hospital.Secondary objectives are to evaluate longitudinal changes at 26, 52, 72, and 96 weeks after surgery in IWQOL-Lite-CT component scores and total score, SF-12 v2, WPAI, GPAQ, QDIS-7 obesity score, body weight, body mass index, waist circumference, body composition, obesity-related health conditions, laboratory data, medication use, postoperative complications, and CT-derived image indicators obtained in routine clinical practice.
Exploratory objectives include the evaluation of the reliability, validity, and responsiveness of the QDIS-7 obesity version, clinical factors associated with changes in patient-reported outcomes, and associations between body composition or image-derived indicators and changes in patient-reported outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the IWQOL-Lite-CT physical function composite score from baseline to 72 weeks after surgery.
Key secondary outcomes
Changes in IWQOL-Lite-CT component scores and total score at 26, 52, 72, and 96 weeks after surgery.
Changes in SF-12 v2, WPAI, GPAQ, and QDIS-7 obesity scores at 26, 52, 72, and 96 weeks after surgery.
Values, changes from baseline, and percentage changes in body weight, body mass index, waist circumference, and body composition indicators at each assessment time point.
Values and changes from baseline in laboratory data at each assessment time point.
Frequencies and proportions of presence, improvement, remission, new onset, or worsening of obesity-related health conditions at each assessment time point.
Use of pharmacotherapy, including anti-obesity medications, before and after surgery.
Incidence, severity, and seriousness of postoperative complications.
Distribution of social background factors and motivations for weight loss.
Longitudinal changes in image-derived indicators obtained from CT images acquired in routine clinical practice.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age 18 years or older.
Scheduled to undergo metabolic and bariatric surgery under routine insured clinical care at Kobe University Hospital or Chibune Hospital.
Provided written informed consent to participate in this study.
Key exclusion criteria
Individuals who are unable to sufficiently understand the Japanese questionnaires and respond based on their own will.
Individuals currently undergoing treatment for malignancy, including hormone therapy.
Individuals undergoing dialysis.
Individuals who are pregnant or planning pregnancy.
Individuals judged by the principal investigator or site investigator to be inappropriate for participation in this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yushi |
| Middle name | |
| Last name | Hirota |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Diabetes and Endocrinology, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5861
hirota@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Motoko |
| Middle name | |
| Last name | Kobayashi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Diabetes and Endocrinology, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5860
Homepage URL
koba0616@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
This study will be funded by departmental research funds of the principal investigator's department.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Medicine, Medical Ethics Committee
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel
078-382-6669
kansatsu@med.kobe-u.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
| 2026 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter prospective observational cohort study of 100 patients with obesity disease who are scheduled to undergo metabolic and bariatric surgery under routine insured clinical care at Kobe University Hospital or Chibune Hospital. Patient-reported outcomes, including IWQOL-Lite-CT, SF-12 v2, WPAI, GPAQ, and QDIS-7, as well as body weight, body composition, obesity-related health conditions, laboratory data, medication use, postoperative complications, and CT-derived image indicators, will be collected from baseline to 96 weeks after surgery. The primary outcome is the change in the IWQOL-Lite-CT physical function composite score from baseline to 72 weeks after surgery.
Management information
Registered date
| 2026 | Year | 05 | Month | 13 | Day |
Last modified on
| 2026 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070439
