UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055091 |
|---|---|
| Receipt number | R000062935 |
| Scientific Title | Evaluating eating behaviors and psychological state in noncommunicable diseases treatment using GLP-1 receptor agonists |
| Date of disclosure of the study information | 2024/07/28 |
| Last modified on | 2025/01/27 23:42:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluating eating behaviors and psychological state in noncommunicable diseases treatment using GLP-1 receptor agonists
Acronym
GLP-1 receptor agonists: effects on eating and psychology
Scientific Title
Evaluating eating behaviors and psychological state in noncommunicable diseases treatment using GLP-1 receptor agonists
Scientific Title:Acronym
GLP-1 receptor agonists: effects on eating and psychology
Region
| Japan |
Condition
Condition
Obesity, obesity with type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine if eating behaviors and psychological state change before and after treatment with GLP-1 receptor agonists.
Basic objectives2
Others
Basic objectives -Others
To conduct Ecological Momentary Assessment and analyze the extracted psychosomatic symptoms.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in psychological assessment scales 1 to 3 months after the start of GLP-1 receptor agonists administration
Key secondary outcomes
The relationship between changes in psychological assessment scales and medical record information
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with obesity or obesity-related type 2 diabetes scheduled to start GLP-1 receptor agonists (liraglutide, lixisenatide, dulaglutide, semaglutide, tirzepatide).
2. Those who can respond to EMA via smartphone in their daily life.
3. Those who own a smartphone.
4. Those who have received sufficient explanation about the study, fully understand it, and have freely given their consent to participate.
Key exclusion criteria
1.Individuals who are unable to utilize the study app
2.Individuals deemed inappropriate to participate in the study by physician judgement
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Aika |
| Middle name | |
| Last name | Miya |
Organization
Hokkaido University Hospital
Division name
Diabetes and Endocrinology
Zip code
060-8638
Address
N15W7, Kita-ku, Sapporo , Japan
TEL
+81-11-706-5915
miyaaika@huhp.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Aika |
| Middle name | |
| Last name | Miya |
Organization
Hokkaido University Hospital
Division name
Diabetes and Endocrinology
Zip code
060-8638
Address
N15W7, Kita-ku, Sapporo, Japan
TEL
+81-11-706-5915
Homepage URL
miyaaika@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita14 Nishi5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study targeting patients with obesity or obesity-related type 2 diabetes.
Management information
Registered date
| 2024 | Year | 07 | Month | 28 | Day |
Last modified on
| 2025 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062935
