UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061705 |
|---|---|
| Receipt number | R000062325 |
| Scientific Title | Study to investigate the effects of incretin drugs on depression, quality of life, and eating habits in Type 2 diabetes and obesity |
| Date of disclosure of the study information | 2026/05/28 |
| Last modified on | 2026/05/27 16:13:33 |
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Basic information
Public title
Study to investigate the effects of incretin drugs on depression, quality of life, and eating habits in Type 2 diabetes and obesity
Acronym
GLP-1 QUEST
Scientific Title
Study to investigate the effects of incretin drugs on depression, quality of life, and eating habits in Type 2 diabetes and obesity
Scientific Title:Acronym
GLP-1 QUEST
Region
| Japan |
Condition
Condition
Diabetes, Obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in treatment response indicators 12 weeks after initiation of incretin treatment.
Key secondary outcomes
Changes in depression and anxiety
Changes in quality of life
Changes in diet
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Satoh-Asahara |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Endocrinology, Metabolism and Hypertension Research, Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa-mukaihata, Fushimi-ku, Kyoto, Japan
TEL
075-641-9161
nsatoh@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Satoh-Asahara |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Endocrinology, Metabolism and Hypertension Research, Clinical Research
Zip code
612-8555
Address
1-1 Fukakusa-mukaihata, Fushimi-ku, Kyoto, Japan
TEL
075-641-9161
Homepage URL
nsatoh@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyoto Medical Center
Address
1-1 Fukakusa-mukaihata, Fushimi-ku, Kyoto, Japan
Tel
075-641-9161
nsatoh@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立病院機構京都医療センター(京都府)、独協医科大学埼玉医療センター(埼玉県)、澤木内科・糖尿病クリニック(大阪府)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To reduce sampling bias, all patients at each site who met the inclusion criteria (or were randomly selected from those who met the inclusion criteria using a random number table) were asked to participate in the study. The term 'newly prescribed incretin' will include 'patients who are newly prescribed incretin' as well as 'patients for whom an incretin prescription is confirmed at their next visit (e.g. if agreed within the practice with the patient)'. Specifically, all study subjects who are seen for diabetes or obesity treatment and meet the eligibility criteria for the study will be included in the list of study subjects. The principal investigator or research assistant will provide an overview of the study to those listed, and those research subjects who express an interest in participating in this study will be informed of the study's main purpose both orally and in writing. After obtaining the research subject's free and voluntary consent to participate in the study, the consent form is requested, distributed and collected, and the subject is enrolled in the study by indicating on the list of research subjects whether or not they are included in this study.
Management information
Registered date
| 2026 | Year | 05 | Month | 27 | Day |
Last modified on
| 2026 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062325
