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

Phase 4

Recruiting

• Conditions: Diabetes; Diabetes Mellitus

• Registration Number: JPRN-jRCT1041230070
• Lead Sponsor: Yabe Daisuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 90

Inclusion 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

Exclusion 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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c change from baseline to 12 weeks after treatment based on food preferences and eating behavior

Secondary Outcome Measures

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