UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060054 |
|---|---|
| Receipt number | R000068676 |
| Scientific Title | A prospective cohort study evaluating the impact of lifestyle intervention induced initial weight change on visceral fat area and body composition after initiation of anti obesity pharmacotherapy |
| Date of disclosure of the study information | 2025/12/11 |
| Last modified on | 2025/12/11 15:04:02 |
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Basic information
Public title
Impact of lifestyle intervention on visceral fat area after initiation of anti-obesity pharmacotherapy in patients with obesity
Acronym
LIVA Study
Scientific Title
A prospective cohort study evaluating the impact of lifestyle intervention induced initial weight change on visceral fat area and body composition after initiation of anti obesity pharmacotherapy
Scientific Title:Acronym
LIVA PRO Study
Region
| Japan |
Condition
Condition
Obesity disease
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to prospectively evaluate how initial weight changes induced by lifestyle intervention (dietary and exercise counseling) influence subsequent changes in body weight, visceral fat area, and body composition after initiation of anti-obesity pharmacotherapy (semaglutide or tirzepatide) in patients with obesity disease.
In addition, this study aims to identify factors associated with weight change using multivariate analyses.
Basic objectives2
Others
Basic objectives -Others
To explore the associations between initial weight changes induced by lifestyle intervention and subsequent changes in body weight, visceral fat area, and body composition after initiation of anti-obesity pharmacotherapy. In addition, this study aims to identify factors influencing these changes using multivariate analyses.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in visceral fat area, measured by abdominal CT, from the start of lifestyle intervention (baseline) to 6 months after initiation of anti-obesity pharmacotherapy.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients receiving care at the Asahi Life Foundation Institute of Adult Diseases who meet the following conditions and provide written informed consent to participate in the study
1 Patients with hypertension, dyslipidemia, or impaired glucose tolerance, and who meet one of the following BMI criteria
- BMI >= 35 kg/m^2, or
- BMI >= 27 kg/m^2 with at least two obesity related comorbidities.
2 Patients who initiate lifestyle intervention (dietary and exercise counseling) for the purpose of receiving anti obesity pharmacotherapy (semaglutide or tirzepatide).
Key exclusion criteria
1 Patients who are pregnant, or those with severe hepatic or renal dysfunction, or malignant disease.
2 Patients who are using anti-obesity medications other than semaglutide or tirzepatide.
3 Patients whose weight may be affected by recent adjustments in medications such as antidiabetic agents, steroids, antidepressants, or antipsychotic drugs.
4 Patients deemed unsuitable for study participation by the attending physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ryusuke |
| Middle name | |
| Last name | Nakada |
Organization
Asahi Life Foundation Institute of Adult Diseases Hospital
Division name
Department of Diabetes and Metabolism
Zip code
103-0002
Address
2-2-6 Nihonbashi-Bakurocho, Chuo-ku, Tokyo 103-0002, Japan
TEL
03-3639-5501
ryu25160178@gmail.com
Public contact
Name of contact person
| 1st name | Shigehisa |
| Middle name | |
| Last name | Nakayama |
Organization
Asahi Life Foundation Institute of Adult Diseases Hospital
Division name
General Affairs Section
Zip code
130-0022
Address
2-2-6 Nihonbashi-Bakurocho, Chuo-ku, Tokyo 103-0002, Japan
TEL
03-3639-5501
Homepage URL
ryuryunakada@yahoo.co.jp
Sponsor or person
Institute
Asahi Life Foundation Institute of Adult Diseases Hospital
Institute
Department
Personal name
Funding Source
Organization
Asahi Life Foundation Institute of Adult Diseases Hospital
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
Ethics Committee, Institute of Medical Science, Asahi Life Foundation
Address
2-2-6 Nihonbashi-Bakurocho, Chuo-ku, Tokyo 103-0002, Japan
Tel
03-3639-5501
S-nakayama@asahi-life.or.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 | 12 | Month | 11 | 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 | 12 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study conducted at the Institute of Medical Science, Asahi Life Foundation. The study enrolls patients with obesity who initiate lifestyle intervention as part of routine clinical care, followed by anti-obesity pharmacotherapy (semaglutide or tirzepatide). Data are obtained from medical records, and no additional procedures or allocation are performed beyond standard practice. The primary outcome is the change in visceral fat area six months after the initiation of lifestyle intervention. Participation in the study does not alter clinical management, and the study is conducted with careful consideration to ensure that no disadvantage or burden is imposed on participants.
Management information
Registered date
| 2025 | Year | 12 | Month | 11 | Day |
Last modified on
| 2025 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068676
