Tokyo, Dec. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060054) titled 'Impact of lifestyle intervention on visceral fat area after initiation of anti-obesity pharmacotherapy in patients with obesity' on Dec. 11.

Study Type: Observational

Primary Sponsor: Institute - Asahi Life Foundation Institute of Adult Diseases Hospital

Condition: Condition - Obesity disease Classification by malignancy - Others Genomic information - NO

Objective: 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

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 Size - 30

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068676

Disclaimer: Curated by HT Syndication.