UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061620 |
|---|---|
| Receipt number | R000070499 |
| Scientific Title | A prospective study on changes in insulin resistance during the early phase of teprotumumab administration |
| Date of disclosure of the study information | 2026/05/18 |
| Last modified on | 2026/05/18 22:12:20 |
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Basic information
Public title
A study evaluating changes in insulin resistance during the early phase of teprotumumab administration for thyroid eye disease
Acronym
Teprotumumab and Insulin Resistance Study
Scientific Title
A prospective study on changes in insulin resistance during the early phase of teprotumumab administration
Scientific Title:Acronym
Prospective study of insulin resistance changes with early teprotumumab administration
Region
| Japan |
Condition
Condition
Thyroid eye disease
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the hypothesis that insulin resistance (HOMA-IR) increases from baseline to after the third dose in patients receiving teprotumumab for thyroid eye disease.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HOMA-IR (homeostasis model assessment of insulin resistance) from baseline to after the third dose of teprotumumab (approximately 6-9 weeks).
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients meeting all of the following criteria:
1.Diagnosed with thyroid eye disease (TED).
2.Scheduled to initiate treatment with teprotumumab.
3.Judged to have active disease based on the teprotumumab appropriate use guide (satisfying either a Clinical Activity Score (CAS) of >= 3 out of 7 points, or inflammatory findings on orbital MRI).
4.Able to provide written informed consent for study participation.
5.18 years of age or older.
Key exclusion criteria
Patients meeting any of the following criteria are excluded:
1.Type 1 diabetes mellitus or severe diabetes with suspected pancreatic beta-cell depletion.
2.Currently receiving high-dose steroid therapy.
3.Active inflammatory bowel disease (Crohn's disease or ulcerative colitis).
4.Obvious acute infection.
5.Pregnant or breastfeeding women.
6.Patients otherwise deemed inappropriate for the study by the investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Harada |
Organization
Kagawa University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-891-2230
muraeri0217@gmail.com
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Harada |
Organization
Kagawa University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-891-2230
Homepage URL
muraeri0217@gmail.com
Sponsor or person
Institute
Kagawa univercity
Institute
Department
Personal name
Funding Source
Organization
Kagawa univercity
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
Kagawa University Faculty of Medicine Ethics Committee
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
Tel
087-898-5111
kenkyushien-m@kagawa-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 18 | 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
| 2026 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study targeting patients receiving teprotumumab as standard clinical care for thyroid eye disease. Participation in the study will not alter the medical treatment provided, such as dosage or administration intervals. Data will be collected from blood tests (glucose indices, IGF-1/GH axis, etc.), body composition measurements (InBody), and ophthalmological evaluations (CAS, etc.) performed before treatment, and after the 3rd and 8th doses (approximately 24-30 weeks). In addition, evaluation of glycemic variability using continuous glucose monitoring (CGM: FreeStyle Libre) and glucose tolerance using a 75g oral glucose tolerance test (OGTT) will be conducted within the scope of routine clinical practice.
This study is conducted using research funds (management expenses grants, donations) from the Department of Endocrinology and Metabolism, without funding or benefits from corporate entities, and the researchers have no conflicts of interest to disclose.
Management information
Registered date
| 2026 | Year | 05 | Month | 18 | Day |
Last modified on
| 2026 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070499
