UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058583 |
|---|---|
| Receipt number | R000066985 |
| Scientific Title | Effects of Medical Treatment for Obesity on Exercise Tolerance |
| Date of disclosure of the study information | 2025/07/24 |
| Last modified on | 2025/07/24 13:19:18 |
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Basic information
Public title
Effects of Medical Treatment for Obesity on Exercise Tolerance
Acronym
Effects of Medical Treatment for Obesity on Exercise Tolerance
Scientific Title
Effects of Medical Treatment for Obesity on Exercise Tolerance
Scientific Title:Acronym
Effects of Medical Treatment for Obesity on Exercise Tolerance
Region
| Japan |
Condition
Condition
Patients with Obesity Undergoing Treatment with Semaglutide or Tirzepatide
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Physical activity and patient-reported outcomes will be assessed before initiation, during the course, and at the end of treatment with semaglutide or tirzepatide. In addition, clinical data including blood tests, urinalysis, and medical records will be collected at baseline, during treatment, and at the 6-month follow-up visit. Exercise capacity will also be evaluated using cardiopulmonary exercise testing (CPX).
Basic objectives2
Others
Basic objectives -Others
This study aims to comprehensively evaluate changes in exercise capacity using cardiopulmonary exercise testing in patients with obesity treated with anti-obesity medications. It will explore the contribution of improvements in organ functions-specifically cardiac, pulmonary, and skeletal muscle function-to enhanced exercise performance. Furthermore, the study seeks to assess whether improvements in exercise capacity are associated with reductions in cardiovascular risk.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in exercise capacity before and after the initiation of treatment
Key secondary outcomes
Evaluation of pre- and post-treatment changes in body weight, body composition, obesity-related comorbidities, and findings from clinical tests and functional assessments
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with obesity who receive treatment with semaglutide or tirzepatide during the registration period and meet either of the following criteria will be included in the study:
A body mass index (BMI) of 27 kg/m2 or higher; or
A BMI below 30 kg/m2 accompanied by two or more obesity-related comorbidities.
The obesity-related comorbidities considered for inclusion are as follows:
impaired glucose tolerance, dyslipidemia, hypertension, hyperuricemia or gout, coronary artery disease, cerebral infarction or transient ischemic attack, non-alcoholic fatty liver disease (NAFLD), menstrual disorders or infertility, obstructive sleep apnea, musculoskeletal disorders, and obesity-related kidney disease.
Key exclusion criteria
Participants will be excluded from the study if they meet any of the following conditions:
Pregnant or breastfeeding women;
Patients with a body weight of 135 kg or more;
Any other individuals deemed inappropriate for participation in this study by the investigator.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Takabayashi |
Organization
Shiga University of Medical Science
Division name
Department of Cardiovascular Medicine
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, Japan
TEL
077-548-2213
ktkb@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Takabayashi |
Organization
Shiga University of Medical Science
Division name
Department of Cardiovascular Medicine
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, Japan
TEL
077-548-2213
Homepage URL
ktkb@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Shiga University of Medical Science
Address
Seta Tsukinowa-cho, Otsu, Shiga, Japan
Tel
077-548-3618
hqrec@belle.shiga-med.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
| 2025 | Year | 07 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2030 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2025 | Year | 07 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066985
