A study evaluating changes in insulin resistance during the early phase of teprotumumab administration for thyroid eye disease

A prospective study on changes in insulin resistance during the early phase of teprotumumab administration - Prospective study of insulin resistance changes with early teprotumumab administration

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061620

Enrollment

Registered

2026-05-18

Start date

2026-04-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid eye disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Change in HOMA-IR (homeostasis model assessment of insulin resistance) from baseline to after the third dose of teprotumumab (approximately 6-9 weeks).	—

Countries

Japan

Contacts

Public ContactEri Harada

Kagawa University Hospital Department of Endocrinology and Metabolism

muraeri0217@gmail.com087-891-2230

Outcome results