UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055262 |
|---|---|
| Receipt number | R000063143 |
| Scientific Title | Investigation of Changes in Clinical Parameters Associated With Treatment With Tirzepatide, a Novel Antidiabetic Agent |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2026/08/27 07:27:53 |
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Basic information
Public title
Changes in Blood Sugar, Body Weight, Muscle Mass, and Body Fat During Tirzepatide Treatment in Patients With Type 2 Diabetes
Acronym
Tirzepatide Blood Sugar and Body Composition Study
Scientific Title
Investigation of Changes in Clinical Parameters Associated With Treatment With Tirzepatide, a Novel Antidiabetic Agent
Scientific Title:Acronym
Tirzepatide Clinical Parameters Study
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively evaluate changes in glycemic parameters, body weight, and body composition during tirzepatide treatment in patients with type 2 diabetes and to examine the associations between changes in body weight and regional muscle mass.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in glycated hemoglobin (HbA1c) from baseline to week 48.
Key secondary outcomes
Changes in body weight, body mass index, waist circumference, body fat mass, and muscle mass of the trunk, bilateral arms, and bilateral legs from baseline to weeks 12, 24, and 48; changes in continuous glucose monitoring metrics, including time in range, time above range, time below range, and coefficient of variation; changes in handgrip strength and performance on the five-times sit-to-stand test from baseline to week 48; and associations between percentage changes in body weight and regional muscle mass at week 48.
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
Patients with type 2 diabetes who received tirzepatide as part of routine clinical care at our hospital, had the required clinical data available at baseline and weeks 12, 24, and 48, and maintained unchanged background glucose-lowering therapy throughout the 48-week observation period. Switching from dulaglutide to tirzepatide at baseline was permitted.
Key exclusion criteria
Patients with advanced renal dysfunction, defined as an estimated glomerular filtration rate below 30 mL/min/1.73 m2, proliferative diabetic retinopathy, diabetic ketoacidosis, liver cirrhosis, uncontrolled endocrine disorders, active infections, malignancies, other serious systemic diseases, or sarcopenia according to the Asian Working Group for Sarcopenia 2019 criteria were excluded. Patients who remained on a lower tirzepatide dose for nonmedical reasons were also excluded from the retrospective analysis.
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
skojima.matsudo1380@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
新松戸中央総合病院(千葉県)
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
Individual participant data will not be shared.
IPD sharing Plan description
Because of participant privacy considerations and the scope of the approved research protocol, de-identified individual participant data will not be shared with third parties.
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
| 2026 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063143
