UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055262 |
|---|---|
| Receipt number | R000063143 |
| Scientific Title | Investigating the changes in various clinical parameters induced by tirzepatide |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/08/18 12:01:50 |
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Basic information
Public title
Investigating the changes in various clinical parameters induced by tirzepatide
Acronym
Investigating the changes in various clinical parameters induced by tirzepatide
Scientific Title
Investigating the changes in various clinical parameters induced by tirzepatide
Scientific Title:Acronym
Investigating the changes in various clinical parameters induced by tirzepatide
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate how body composition, including muscle mass, changes in response to weight alterations induced by tirzepatide administration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tirzepatide was introduced to patients with type 2 diabetes who were either outpatients or inpatients at our hospital. Comprehensive evaluations of HbA1c, random blood glucose, liver and kidney function, and lipid metabolism were conducted at the time of introduction, 12 weeks, and 24 weeks afterward.
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients were adults aged 20 years or older, diagnosed with type 2 diabetes, who could regularly attend our hospital, with HbA1c below 10.0% and BMI of 23 kg/m2 or higher.
Key exclusion criteria
Exclusion criteria included patients with type 1 diabetes or those currently undergoing treatment for active diseases such as hepatitis, pancreatitis, or infections.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shiori |
| Middle name | |
| Last name | Kojima |
Organization
Shinmatsudo Central General Hospital
Division name
Department of Endocrinology, Diabetes and Metabolism
Zip code
2700034
Address
Department of Endocrinology, Diabetes and Metabolism, Shinmatsudo Central General Hospital 1-380 Shinmatsudo, Matsudo, Tokyo, 270-0034, Japan
TEL
0473451111
kobatons@gmail.com
Public contact
Name of contact person
| 1st name | Shiori |
| Middle name | |
| Last name | Kojima |
Organization
Shinmatsudo Central General Hospital
Division name
Department of Endocrinology, Diabetes and Metabolism
Zip code
2700034
Address
Department of Endocrinology, Diabetes and Metabolism, Shinmatsudo Central General Hospital 1-380
TEL
0473451111
Homepage URL
kobatons@gmail.com
Sponsor or person
Institute
Shinmatsudo Central General Hospital
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
Shinmatsudo Central General Hospital
Address
Department of Endocrinology, Diabetes and Metabolism, Shinmatsudo Central General Hospital 1-380 Shinmatsudo, Matsudo, Tokyo, 270-0034, Japan
Tel
0473451111
kobatons@gmail.com
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
| 2025 | Year | 06 | 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
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2031 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Improvements in blood glucose levels, various test parameters, weight loss, and other biochemical tests are anticipated with tirzepatide administration.
Management information
Registered date
| 2024 | Year | 08 | Month | 16 | Day |
Last modified on
| 2025 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063143
