Tokyo, July 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058583) titled 'Effects of Medical Treatment for Obesity on Exercise Tolerance' on July 24.
Study Type:
Observational
Primary Sponsor:
Institute - Shiga University of Medical Science
Condition:
Condition - Patients with Obesity Undergoing Treatment with Semaglutide or Tirzepatide
Classification by malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 75
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066985
Disclaimer: Curated by HT Syndication.
