Treatment response and eating behavior patterns with GLP-1/GIP co-receptor agonists

JRCT ID: jRCT1041230070

Registered date:18/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diabetes
• Date of first enrollment: 18/08/2023
• Target sample size: 90
• Study type: Observational

Outcome(s)

• Primary Outcome: HbA1c change from baseline to 12 weeks after treatment based on food preferences and eating behavior

Secondary Outcome

Based on food preferences and eating behavior,

Percentage of patients achieving target HbA1c at 12 and 52 weeks
Percentage of patients achieving HbA1c <7.0% at Weeks 12 and 52
Weight change from baseline to Week 12,52
Body composition change from baseline to Week 12,52
Change in grip strength from baseline to Week 12,52
Change in total energy intake and intake of the three macronutrients (FFQ) from baseline to Weeks 12 and 52
Change in urinary albumin (or urinary protein if diabetic nephropathy stage 3 or later) from baseline to Weeks 12 and 52

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Include criteria: Patients with type 2 diabetes who have been switched from a GLP-1 receptor agonist to a GLP-1/GIP co-receptor agonist, who understand the purpose of the study and give 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: Yabe Daisuke