Tokyo, May 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061620) titled 'A study evaluating changes in insulin resistance during the early phase of teprotumumab administration for thyroid eye disease' on May 18.
Study Type:
Observational
Primary Sponsor:
Institute - Kagawa univercity
Condition:
Condition - Thyroid eye disease
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Eligibility:
Age-lower limit - 18
years-old
= 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 Size - 10
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070499
Disclaimer: Curated by HT Syndication.
