Tokyo, May 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061705) titled 'Study to investigate the effects of incretin drugs on depression, quality of life, and eating habits in Type 2 diabetes and obesity' on May 28.
Study Type:
Observational
Primary Sponsor:
Institute - Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Condition:
Condition - Diabetes, Obesity
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - In diabetic and obese patients newly prescribed with incretins:
1. determine changes in treatment effect indicators (weight, glucose metabolism, etc.) after prescription
2. examine changes in depression and anxiety after prescription
3. examine changes in quality of life after prescription
4. examine changes in eating habits after prescription
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. age: 18 years and over
2. new prescriptions in accordance with the following indication criteria for each incretin drugs
3. those who understand the purpose of the study and give their consent.
*1: Indication criteria The following indications are to be followed in accordance with the package insert for each drug:
1. persistent GIP/GLP-1 receptor agonist tiruzepatide injection Manjaro subcutaneous injection 2.5mg/5mg/7.5mg/10mg/12.5mg/15mg Ateos, Eli Lilly Japan K.K., approval numbers 30400AMX00420/ 30400AMX00421/ 30400AMX 00422/ 30400AMX00423/ 30400AMX00424/ 30400AMX00425, Revised July 2023 (5th edition)
2. Type 2 diabetes therapeutic agent Semaglutide (genetical recombination), sustained GLP-1 receptor agonist Ozempic subcutaneous injection 2mg, Novo Nordisk Pharma K.K. , Approval No. 23000AMX00443000, Revised: Feb 2024 (Version 3)
3. Oral GLP-1 receptor agonist semaglutide (genetic recombination) Liberusus Tablets 3mg/7mg/14mg, Novo Nordisk Pharma K.K., Approval No. 30200AMX00513000 / 30200AMX00514000/ 30200AMX00515000, Revised February 2024 (4th edition)
4. Obesity treatment Semaglutide (genetical recombination), sustained GLP-1 receptor agonist Ugobi subcutaneous injection 0.25 mg SD/0.5 mg SD/1.0 mg SD/1.7 mg SD/2.4 mg SD, Novo Nordisk Pharma K.K., Approval No. 30500AMX00105000/ 30500AMX00106000/ 30500AMX00107000/ 30500AMX00108000/ 30500AMX00109000, revised Nov 2023 (2nd edition)
Key exclusion criteria - 1. those with a history of prescribing incretin (including liraglutide, exenatide, lixisenatide and dulaglutide in addition to the drugs under study.
2. those who have difficulty following the instructions of the principal investigator or a sub-investigator.
3. those who are judged by the principal investigator or a research assistant physician to have difficulty in answering the various questionnaires (depression/anxiety, quality of life, nutritional survey, eating habits).
4. others who are judged by the physician to be undesirable to participate in the research.
Target Size - 200
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2024 Year 05 Month 02 Day
Date of IRB - 2024 Year 05 Month 08 Day
Anticipated trial start date - 2024 Year 06 Month 26 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062325
Disclaimer: Curated by HT Syndication.
