Treatment Response and Eating Behavior Patterns in Patients Using Semaglutide

JRCT ID: jRCT1041240034

Registered date:24/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: obesity
• Date of first enrollment: 14/05/2024
• Target sample size: 30
• Study type: Observational

Outcome(s)

Primary Outcome

Difference in BMI changes based on dietary preferences between the focus period and the reference period
(The 24 weeks prior to drug administration are the reference (control) period, and the 24 weeks from the start of drug administration are the focus (exposure) period.)

Secondary Outcome

Based on dietary preferences
Differences in the changes in body weight, BMI, blood pressure, grip strength, respiratory quotient, body composition, bone density, blood biochemistry test results, and urine test (urine protein quantification) between the focus period and the reference period (The 24 weeks prior to drug administration are the reference (control) period, and the 24 weeks from the start of drug administration are the focus (exposure) period.)
Changes in body weight and BMI from baseline to 0, 24, and 52 weeks after administration
Changes in body weight, BMI, blood pressure, grip strength, respiratory quotient, body composition, bone density, dietary content (total energy intake, various nutrients, intake of each food item), blood biochemistry test results, and urine test (urine protein quantification) from baseline to 12, 24, and 52 weeks after administration
Changes in dietary preferences at 12, 24, and 52 weeks after drug administration
Based on dietary content
Differences in the changes in body weight, BMI, blood pressure, grip strength, respiratory quotient, body composition, bone density, blood biochemistry test results, and urine test (urine protein quantification) between the focus period and the reference period (The 24 weeks prior to drug administration are the reference (control) period, and the 24 weeks from the start of drug administration are the focus (exposure) period.)
Changes in body weight, BMI, blood pressure, grip strength, respiratory quotient, body composition, bone density, dietary content (total energy intake, various nutrients, intake of each food item), and blood biochemistry test results from baseline to 12, 24, and 52 weeks after administration
Medication adherence rate and medication details during the drug administration period

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Include criteria: Among obese patients newly started on semaglutide, those who understood the purpose of the study and gave their consent

Exclude criteria

1) Patients who have difficulty following the instructions of the principal investigator or sub-investigator
2) Other patients who are deemed inappropriate for this study by the principal investigator or sub-investigator.

Related Information

• Primary Sponsor: Kato Takehiro