UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060936 |
|---|---|
| Receipt number | R000069681 |
| Scientific Title | Usefulness of GLP-1 receptor agonists in patients with type 2 diabetes who are receiving antipsychotic therapy and have obesity or fatty liver |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/14 15:09:29 |
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Basic information
Public title
Usefulness of GLP-1 receptor agonists in patients with type 2 diabetes who are receiving antipsychotic therapy and have obesity or fatty liver
Acronym
Usefulness of GLP-1 receptor agonists in patients receiving antipsychotic therapy
Scientific Title
Usefulness of GLP-1 receptor agonists in patients with type 2 diabetes who are receiving antipsychotic therapy and have obesity or fatty liver
Scientific Title:Acronym
Usefulness of GLP-1 receptor agonists in patients receiving antipsychotic therapy
Region
| Japan |
Condition
Condition
Patients with type 2 diabetes who are receiving antipsychotic therapy and have obesity or fatty liver
Classification by specialty
| Endocrinology and Metabolism | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to clarify the usefulness of GLP-1 receptor agonists in patients with type 2 diabetes who are receiving antipsychotic medications and who also have obesity or fatty liver disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes of BMI, serum ALT levels and HbA1c
Key secondary outcomes
body fat percentage and muscle mass
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with type 2 diabetes who are currently receiving antipsychotic medication and have not yet been treated with a GLP-1 receptor agonist
(2) BMI greater than 27 or diagnosis of fatty liver by imaging (ultrasound or CT)
Patients who meet both criteria (1) and (2) will begin treatment with a GLP-1 receptor agonist.
Key exclusion criteria
Inability to comply with GLP-1 receptor agonist therapy
Any other condition judged inappropriate by the attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshimichi |
| Middle name | |
| Last name | Haruna |
Organization
Osaka Prefectural Hospital Organization Osaka Psychiatric Medical Center
Division name
Department of Medical Affairs
Zip code
573-0022
Address
3-16-21 Miyanosaka, Hirakata City, Osaka 573-0022, Japan
TEL
072-847-3261
apple-123-grape@ab.auone-net.jp
Public contact
Name of contact person
| 1st name | Yoshimichi |
| Middle name | |
| Last name | Haruna |
Organization
Osaka Prefectural Hospital Organization Osaka Psychiatric Medical Center
Division name
Department of Medical Affairs
Zip code
573-0022
Address
3-16-21 Miyanosaka, Hirakata City, Osaka 573-0022, Japan
TEL
072-847-3261
Homepage URL
apple-123-grape@ab.auone-net.jp
Sponsor or person
Institute
Osaka Prefectural Hospital Organization Osaka Psychiatric Medical Center
Institute
Department
Personal name
Funding Source
Organization
Osaka Prefectural Hospital Organization Osaka Psychiatric Medical Center
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
Osaka Prefectural Hospital Organization Osaka Psychiatric Medical Center
Address
3-16-21 Miyanosaka, Hirakata City, Osaka 573-0022, Japan
Tel
072-847-3261
harunayo@opho.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
| 2026 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing particular
Management information
Registered date
| 2026 | Year | 03 | Month | 14 | Day |
Last modified on
| 2026 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069681
